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Om140bt1000bt1500bt2000-Plusbt3000plusbt3500pdf PDF
Om140bt1000bt1500bt2000-Plusbt3000plusbt3500pdf PDF
P/N: MO04444-00ING
SOFTWARE VERSION 14.0
Rev. 0, 10/2009
This product conforms to the safety requirements of the Council Directives 98/79/EEC of 27
October 1998 (European Parliament) regarding the In-Vitro Diagnostic Medical Devices. This
directive is in accordance with the Article 2, Paragraph 2 of the Directive 89/336/EEC, which
ceases to apply to the products complying with the present directive. Refer to Paragraph 7,
Article No.1 of the IEC Official Gazette No. L331 of Dec. 1998.
It also conforms to Italian Regulations CEI EN 61010-01 and CEI EN 61326-1 (EMC).
The conformity is attested when the equipment is installed in accordance with the conditions
outlined in the manual
CHAPTER A
1. INTRODUCTION Page: 2
2. BASIC OPERATING PRINCIPLES OF THE ANALYZER Page: 3
3. SYMBOLS: explanation of the used or applied symbols Page: 4
4. BRIEF DESCRIPTION OF THE SYSTEM Page: 9
4.1. Front view of the analyzer Page: 9
4.2. Rear Panel Controls and Connectors Page: 11
4.3. Modules Page: 13
CHAPTER B
1. INSTALLATION Page: 2
1.1. Unpacking the Analyzer Page: 2
1.2. Installation Page: 4
1.3. Starting the instrument Page: 8
1.3.1. Turning on the instrument for the first time Page: 8
1.3.2. Preliminary checks Page: 9
CHAPTER C
1. FUNCTIONS Page: 2
1.1. Description of the Program Menu Page: 2
1.2. Operating Principles Page: 5
1.2.1. Computations Page: 5
1.2.2. Applied mathematical functions Page: 7
1.2.3. Initial computation Page: 9
1.2.4. Optimization techniques for Clinical Chemistry Page: 9
1.2.5. Methods Description Page: 10
1.3. Analyses Programming Page: 15
1.3.1. Creating a New Code Page: 15
1.3.2. Relation Tests Page: 16
1.3.3. Primary Analytical Parameters Page: 17
1.3.4. Check Parameters Page: 23
1.3.5. Secondary Analytical Parameters Page: 24
1.3.6. Automatic re-runs Page: 27
1.4. Controls Page: 28
1.5. Calibrations Page: 29
1.6. Creating Profiles Page: 34
1.7. Creating the Current Analyses’ Tray Page: 35
CHAPTER D
1. PERFORMANCE AND LIMITS Page: 2
INDEX Page 1 of 6
INDEX – Operator Manual
CHAPTER E
1. OPERATING PROCEDURE Page: 2
1.1. Turning on procedure Page: 2
1.2. Reagents: insertion and removal Page: 2
1.3. Running Standard & Controls (on command or timed) Page: 5
1.4. Samples Page: 7
1.5. Work Lists Page: 13
1.6. Turning off procedure Page: 17
1.7. Access Password Page: 18
CHAPTER F
1. QUALITY CONTROLS Page: 2
1.1. Inserting/modifying controls Page: 2
1.2. Data management Page: 4
1.3. Displaying and processing by lot pairs: Juden graph Page: 6
1.3.1. Westgard Graph Page: 7
1.3.2. Daily Chart Page: 9
1.4. Additional Functions Page: 10
2. POPULATION Page: 11
2.1. Analysis Selection (How to run a Query) Page: 12
2.2. Principal statistics formulas used in Population module Page: 16
2.3. Inserting external analyses Page: 18
2.4. Other menu functions Page: 19
3. PATIENTS’ ARCHIVE Page: 21
3.1. Selection (How to run a Query) Page: 23
3.2. Patients’ report Page: 25
3.3. Printing Reports Page: 27
3.4. Other menu functions Page: 29
CHAPTER G
1. DISPLAYING AND PRINTING RESULTS Page: 2
1.1. Results per Patient Page: 3
1.2. Results per Test Page 8
1.3. Displaying Real-Time data Page: 9
1.4. Reaction graphs Page: 11
1.5. Flags list Page: 13
1.6. Sorting results in real time Page: 14
CHAPTER H
1. ANALYZER TECHNICAL FUNCTIONS Page: 2
1.1. Service Functions Page: 2
1.1.1. Analyzer Utilities Page: 2
1.1.2. Mechanical Calibrations Page: 4
1.2. Diagnostic Functions Page: 6
2. ANALYZER SETUP Page: 10
INDEX Page 2 of 6
INDEX – Operator Manual
CHAPTER I
1. BARCODE AND RELATED FUNCTIONS Page: 2
2. USING THE BARCODE Page: 2
2.1. Barcode on Samples Page: 2
2.2. Reagent Barcode Page: 5
CHAPTER K
1. VACUUM PUMP SYSTEM INSTALLATION/OPERATION Page: 2
1.1. Functional characteristics Page: 2
1.2. System control functions Page: 3
1.3. Waste container (external) Page: 3
1.4. Installation & operation Page: 4
1.5. Maintenance and care Page: 4
1.6. Trouble-shooting Page: 4
1.7. Spare parts for maintenance Page: 5
CHAPTER L
1. ISE MODULE Page: 2
1.1. Introduction Page: 2
1.1.1. Contents of the wooden crates: I.S.E. Page: 3
1.1.2. Applied Mathematical Functions Page: 3
1.2. Performance And Limits Page: 4
1.3. I.S.E. Wash and system shut down Page: 5
1.4. Mechanical Calibrations: I.S.E. Arm Page: 6
2. Operating the I.S.E. Module Page: 7
2.1. Parameters Page: 7
2.2. Programming Standards and Controls Page: 10
2.3. Replacing and Installing Electrodes Page: 13
2.4. Preliminary steps before starting the system Page: 14
2.5. Calibration procedure Page: 15
2.6. Measuring unknown samples Page: 17
3. Precautions, maintenance and Troubleshooting Page: 18
3.1 Precautions for ISE Module usage Page: 18
3.2. Suggestions for performance maintenance Page: 19
3.2.1. I.S.E. Maintenance Page: 20
3.3. Troubleshooting Page: 22
4. Returning The Analyzer To The Tech. Assistance Service Page: 26
5. I.S.E. Module Consumables Page:
CHAPTER M
1. WARNINGS AND PRECAUTIONS Page: 2
1.1. Potential risks during operation and maintenance Page: 2
1.2. Warnings and precautions Page: 3
1.3. Waste disposal Page: 6
1.4. Returning the analyzer to the T.A.S. Page: 6
1.4.1. Operating Analyzer Page: 6
INDEX Page 3 of 6
INDEX – Operator Manual
1.4.2. Not Operating Analyzer Page: 7
1.5. Analyzer safe disposal Page: 8
1.6. Electric and electronic devices disposal Page: 9
CHAPTER N
1. MAINTENANCE AND CARE Page: 2
1.1. Preventive maintenance and Extra Wash Page: 2
1.2. Replacing tubing and accessories Page: 3
1.2.1. Clinical Chemistry Page: 3
1.2.2. Extra wash cuvettes Page: 5
1.2.3. Photometric lamp Page: 5
1.2.4. Dilutors’ piston o-ring Page: 6
1.3. Cleaning the instrument Page: 7
2. MALFUNCTIONS Page: 8
2.1. Troubleshooting Page: 8
2.2. Screen messages Page: 9
2.2.1. Screen messages - Causes and remedies Page: 10
2.2.2. Messages requiring technical assistance Page: 12
2.2.3. Optical system verification messages Page: 14
CHAPTER O
1. TECHNICAL SPECIFICATONS Page: 2
CHAPTER 1
1. ABBREVIATED OPERATING INSTRUCTIONS Page: 2
1.1. Turning on and preliminary procedures Page: 3
1.2. Inserting Reagents for Clinical Chemistry Page: 6
1.3. Analytical calibrations and Controls Page: 7
1.4. Entering Patients and Work Lists Page: 10
1.5. Running Tests Page: 14
1.6. Displaying and Printing Results Page: 15
1.7. Turning off the analyzer Page: 19
CHAPTER 2
2. WARRANTY CONDITIONS Page: 2
• Notes from the manufacturer Page: 3
• Parts/Instruments Return Authorization Page: 4
CHAPTER 3
3. ORDERING INFORMATION Page: 2
3.1. GENERAL TERMS AND CONDITIONS FOR SALE Page 2
3.2. Consumables for the analyzer Page: 3
INDEX Page 4 of 6
INDEX – Operator Manual
CHAPTER 4
4. SOFTWARE EXTENSION:
Page: 2
Serial communication analyzer <-> Host Computer
4.1. General Page: 2
4.2. Patient transmission to analyzer Page: 2
4.3. Results reception Page: 3
4.4. Calculation of check-sum Page: 4
4.5. Wiring diagram of interface cable Page: 5
4.6. Variable communication protocol Page: 6
4.7. Serial communication test programs Page: 17
4.7.1. Program Comunica.exe Page: 17
4.7.2. Program BTPLUS.exe Page: 17
CHAPTER 5
5. INSTALLATION OF THE OPERATING SYSTEM Page: 2
5.1. Preliminary Phase Page: 2
5.2. Setup of the Operating System Page: 5
5.3. Completing the installation Page: 9
5.4. Settings of the Operating System Page: 11
5.5. Installation of analyzer Program Page: 15
5.6. Upgrading the analyzer software Page: 16
CHAPTER 6
6. TECHNICAL ASSISTANCE Page: 2
CHAPTER 7
7. BIBLIOGRAPHY OF ALLIED SUBJECTS Page: 2
CHAPTER 8
8. LIST OF APPLICABLE METHODOLOGIES Page: 2
INDEX Page 5 of 6
INDEX – Operator Manual
ATTENTION: USE OF THE ANALYZER INTERNAL COMPUTER –
DOES NOT APPLY TO BT1500
The computer box of BT analyzers is designed for long-term security and reliability
and is virtually maintenance-free as long as the user does not install any third-
party application programs. If these applications are installed, then they may
damage the operating system registry and may also cause disastrous
consequence for the computer's hard-drive. Biotecnica Instruments S.p.A. will not
be responsible for any damage to the analyzer, its software and data in the hard-
disk in case of improper use of the PC box. This includes also: installation of
external programs, not properly secure net connections (intranet and internet) and
the use of disks without the necessary verification for viruses presence. Biotecnica
Instruments S.p.A. will not be responsible for any damage caused by non
authorized third parties who may open and alter the PC box configuration.
INDEX Page 6 of 6
OPERATOR MANUAL
CHAPTER A
1. INTRODUCTION Page: 2
2. BASIC OPERATING PRINCIPLES OF THE ANALYZER Page: 3
3. SYMBOLS: explanation of the used or applied symbols Page: 4
4. BRIEF DESCRIPTION OF THE SYSTEM Page: 9
4.1. Front view of the analyzer Page: 9
4.2. Rear Panel Controls and Connectors Page: 11
4.3. Modules Page: 13
IMPORTANT NOTICE
The introduction of access passwords has been
rendered mandatory since 2004 for safeguarding
sensitive data (refer to CHAPTER E, paragraph 1.7.).
NOTE:
Figure 1
5
6
10
7 8 9
Password (F7)
4 - To Insert/Modify Profiles
6 - To Insert Batch
8 - To Run Controls
9 - Analyzer’s Utilities
10 - Mechanical Calibrations
12 - No Results
13 - Reaction Graphs
Simply positioning the cursor on the icons the “hint” will appear (where available), showing a brief
description of the icon function. This is followed (when available) by the function key between
brackets, which allows for the same function or command as the icon. For example, the hint “Reset
(F5)” means that the function key F5 has the same function of the icon. In the same way, in each
menu are shown (when available) the quick commands (e.g. “Insert Batch” (Ctrl+B) means that the
same function is activated by typing simultaneously on the keyboard the keys “Ctrl” and “B”).
GENERAL ICONS
Reduces the window to the upper bar where the analyzer's name appears.
An icon representing refrigeration system operation has been added to the status bar in the main
menu. The "Refrigerator disabled" state may be necessary if the operator decides not to use the
refrigerator for reactions or after a refrigeration operating error generated by the system.
Catalog number
Manufacturer
Storage temperature
Expiry date
Biological hazard
Risk symbols
* Not all symbols are listed here. These are only some examples.
Direct current
Alternating current
Equipotentiality
ON (Main supply)
1 6
4
10
11 9
Figure 2
1
5
3
4
Fig. 3 5 6
3
4
Rear Panel
Fig. 4
IMPORTANT NOTICE:
The illustrated connectors on the Computer Box (Fig. 4 & Fig. 5) may not be the exact representation
due to possible design modifications without notice during the life of this manual. For correct
configuration of the computer panel, please check the panel of Computer Box on the analyzer rear
panel.
Modules definition
• COMPUTER BOX: it is not present in the BT1500. Consists of LCD Monitor, Touch screen,
Main board, Power Supply and peripheral devices.
• READING STATION MODULE: comprises cuvette plate, photometer, diluter, reading unit,
washing station, H2O reservoir and electronics.
• POWER SUPPLY MODULE: houses the main power supply of the analyzer.
• REAGENT TRAY MODULE: is composed of the rotating reagent's tray, the refrigeration
chamber, the bar-code reader and the electronics.
• SAMPLE TRAY MODULE: is composed of the rotating samples tray, the bar-code reader, the
sample tube sensors, the washing wells and the control electronics.
• SAMPLING ARM: is composed of a two-axes based mechanical system accommodating
sampling needle head with built-in electronics including correct position sensor (Encoder).
PHOTOMETER
CUVETTE
WASTE
H2O
COMPUTER
MODULES:
SERUM 1 – COMPUTER BOX
REAGENT 2 – READING STATION
3 – POWER SUPPLY
4 – REAGENT MODULE
5 – SERUM MODULE
6 – SAMPLING ARM
Modules Arrangement
BT1000, BT1500 & BT2000 Plus
Modules definition
• COMPUTER BOX: consists of LCD Monitor, Touch screen, Main board, Power Supply and
peripheral devices.
• READING STATION MODULE: comprises cuvette plate, photometer, diluter, reading unit,
washing station, H2O reservoir and electronics.
• POWER SUPPLY MODULE: houses the main power supply of the analyzer.
• REAGENT TRAY MODULE: is composed of the rotating reagent's tray, the refrigeration
chamber, the bar-code reader and the electronics.
• SAMPLE TRAY MODULE: is composed of the rotating samples tray, the bar-code reader, the
sample tube electrodes, the washing wells and the control electronics.
• ISE MODULE: consists of the electrodes panel, hydraulic path and the electronics.
• SAMPLING ARM (two): is composed of a two-axes based mechanical system accommodating
sampling needle head with built-in electronics including correct position sensor (Encoder).
Modules Arrangement
BT3000 Plus & BT3500
CHAPTER B
1. INSTALLATION Page: 2
1.1. Unpacking the Analyzer Page: 2
1.2. Installation Page: 4
1.3. Starting the instrument Page: 8
1.3.1. Turning on the instrument for the first time Page: 8
1.3.2. Preliminary checks Page: 9
NOTE:
CAUTION
The analyzer is provided with four integral handgrips (two handgrips for BT1000,
BT1500 and BT2000 Plus) located on the left and right sides of the base frame. To lift
or move the instrument from one location to another, always use the handgrips.
ATTENTION: two persons are necessary to move the analyzer.
Arrow Pointing
Upwards
Base
Spring Clip
Figure 1
NOTE:
All the components, when present, shown in the following figures may undergo
modifications over the time. Therefore, it is recommended to verify them accurately
prior to any repair or installation (refer to eventual specific manuals included).
Attention: always verify the shipment check list Mod. 05_28spr, especially for what
concerns accessories and peripherals, as not all analyzer's models are supplied with
all accessories/peripherals. The following instructions are referred to the analyzers
supplied with all accessories and peripherals. In case your analyzer is not supplied
with complete equipment, please ignore the instructions related to the
accessory/peripheral which is not present.
BT1500: as far as this analyzer has an external computer, please refer to its
instructions for peripherals and electrical connections. The analyzer must be
connected to the PC via the USB port located on the left side of the rear panel.
ELECTRICAL CONNECTIONS
Connect main power cable from the instrument to the UPS and connect the latter to the
main wall outlet (Figure 2). Power circuit should respect current laws and have a good
earth connection.
ON-OFF
FUSE
TO THE MAIN POWER
PRINTER POWER
ON-OFF ANALYZER
TO ANALYZER
TO ANALYZER
FROM UPS
Figure 2
TO POWER
Fig. 5
USB PORT
FLUIDIC CONNECTIONS
The external fluidic manifold (Figure 6 – BT1000, BT1500 & BT2000 Plus) located at the
bottom left of the rear panel has three connectors dedicated to H2O intake, discharge of
waste fluids, and a connector for transparent fluid overflow tube. A transparent tube
supplies double distilled water from the external container. The waste probe tube
discharges the analyzer waste (flowing from an internal vacuum pump) to the external
waste container. In addition, the tubes are fitted with quick-connects having built-in shut-off
valves, which in case of disconnection prevents liquid spillage.
Overflow Tube
Fisher connector
Waste Probe
Waste
Probe H2O Intake
The transparent tube (double distilled H2O plus Surface Active Agent i.e. tensioactive -
1ml every liter of water, ratio 1/1000) must be connected to the right connector (H2O
Intake). Its other end goes to the external water container. Connect the liquid level detector
cable (Fisher connector) and the drain tube of the waste probe to the middle connector
(Waste Probe). Insert the waste probe in authorized external waste container (Fig. 7).
Figure 6a
WARNING
1) Do not use the internal vacuum pump system with any other fluid source except the analyzer. The
unauthorized use may result in serious injury to the user and permanent damage to the vacuum
pump system.
Fisher Connector
LEVEL SENSOR
RED LED
Figure 7
Start button
Figure 8
DESCRIPTIVE TABLE
Wash the cuvettes with the proper solution Daily Before turning off
Extra wash of the cuvettes with acid solution Weekly When turning off
Wash I.S.E. module with proper solution Daily When turning off
NOTE:
Patients Menu
Insert Routine/STAT, Insert Batch: these items are
used to enter samples for Routine/STAT and Batch
mode.
Run all pending patients: Restarts the work list after
an interruption.
Repetition for analyses: Selects the repetition by
analyses upon operator's request.
Clear Patient List: Deletes the entire memorized
patients list. The analyzer will request confirmation
before deleting.
Figure 1
Figure 2
Run Standards/Controls: Activates the procedure for running standard/controls.
Export Data: Copies onto a floppy disk or any other desired location, the analytical
parameters. There are two available options: Back-up (for exporting all the analyses) and
Single Test (exports a selection of single tests).
Import Data Copies the above-mentioned parameters from a floppy disk or from any other
location into the analyzer memory. There are two available options: Restore (will import all
parameters) and Single test (imports the exported single tests). The function is allowed only
if modify parameters password is given.
NOTE: when a back-up is imported, all data in the global and current analyses trays
will be overwritten. When a single parameter is imported, it will be placed in the
Global list of analyses. The operator will have then to correctly place it in the Current
tray.
Analyzer Menu
Analyzer’s utilities: provides access to the service procedures
of the analyzer.
Mechanical Calibrations: for making adjustments to mechanical
devices.
Diagnostic: the technical assistance personnel mainly use this
function (see Chapter H).
Figure 3
Utility Menu
Archive Data: this command stores the processed patients’ data
into the patients’ archive.
View reaction’s curves: this command displays on a graph the
reaction’s curves of tests, with print capability.
View results for Analyses: displays results for test.
Setup Analyzer: it is used to define some system parameters. This
command is disabled during analyzer operation. Refer to Setup
Analyzer in Chapter H, paragraph 2.
Sleep: this command sets the analyzer to a standby mode, during
which the cuvettes are washed and the monitor displays the
screensaver. Press the button at the center of the display to exit
from the sleep mode. A reset will occur and the analyzer will be
immediately ready to operate. This option is useful when the
analyzer is not being used for a while, but it must be kept on to
Figure 4 resume work immediately.
Figure 5
1.2.1. COMPUTATIONS
♦ COMPUTING ABSORBANCE (ABS)
End Point
ABS = Mean value of the last points in reading time- second phase - (max 3)
With subtraction of the Blank reagent.
Kinetics
• Linear regression computation
• ABS = (straight line coefficient) x 60 sec
Fixed Time
ABS = ∆ ABS (last reading in second phase – first reading in second phase)
Initial-Rate
• Linear regression computation
• ABS = Straight line coefficient
In case test is unstable:
• Linear regression computation
• Elimination of 49% of the most distant points from the straight line
• ABS re-computation
Sample-Blank (A)
ABS = Last reading of the second phase – last reading of the first phase x K*
* K = Volumetric factor
ABS = L2 - L1
Sample-Blank A-b
Blank: R1 + R2
1st phase: R1 + Serum
2nd phase: R2
Computation: (Last Reading 2nd phase –Last Reading 1st phase) – blank
Sample-Blank B-b
Blank: R2
1st cuvette: R1 + serum
2nd cuvette: R2 + serum
Computation: (Last Reading 2nd cuvette –Last Reading 1st cuvette) – blank
∑ (T
n
− T )( Li − L)
CC = 1 i
n n
∑ (L
1
i − L) 2
∑ (T
1
i − T )2
where:
n : Number of readings
i : Number of reading (i)
T : Times
L : Readings
♦ Linear Regression
n n
n ∑ ( L ) ∑ (T ) i
2
i
2
∑ (T L ) − n
i i
1
n
1
n
M= 1
n
n 2 (∑ Ti ) 2
∑ (T )
1
i − 1
n
n
⎛ n n
⎞
∑1 Li ⎜⎜ n ∑1 Li ∑ T ⎟⎟ i
− ∑ (Ti Li ) − n 1
n ⎜ 1 n n ⎟
⎜ ⎟
Q= ⎝ ⎠
M
where:
M : Angular coefficient for the line
Q : Final point for the line
X : Point Abscissa
Y : Point Ordinate
♦ Distance between two points
X − x0
Y= ( y1 − y 0 ) + y1
x1 − x0
where:
X : X axis
Y : Y axis
x0 : First Point X Axis
x1 : Second Point X Axis
y0 : First Point Y Axis
y1 : Second Point Y Axis
vS + vR1
K=
vS + vR1 + vR2
where:
K : Volumetric factor
vS : Serum volume
vR1 : First reagent volume
vR2 : Second reagent volume
A2 A3
A1
Fixed Time
In this type of reaction, there is an increase (or decrease) of the absorbance during both
incubation’s and reading’s phases. However, the slope of the line may not be the same during the
two phases. The reaction graph displayed to the user is not always linear, but can also appear as
piecewise linear. This is because the graph is obtained by the union of the read points that may not
be aligned. A regression line is calculated during both incubation’s and reading’s phases. These
provide the user with information about the correct evolution of the reaction. During reading time,
the absorbance delta (∆A) is also computed, which is used for calculating the final concentration for
the analyte in the sample.
It may happen, due to a physical delay, that the instrument does not respect the timing and that
tests are read at a different final time from the one set in the parameters. In this case the analyzer
performs one more reading, traces the regression line between the last two points, moves to the
exact reading time and derives the correct absorbance value from it.
Concentration is calculated by multiplying the absorbance delta (during reading time) by the factor
obtained from the calibration:
Conc. In Sample = Factor x (A3 - A2) (A3 - A2) = ∆A
A1 A2 A3 A1 A2 A3
A1 A2 A3 A1 A2 A3
DELAY TIME INCUBATION READING TIME DELAY TIME INCUBATION READING TIME
TIME TIME
A2
A1
R1+S R2
A1
A2
R1+S R2+S
A1 A2 A3
Only Read
This method is used to read in End Point solely the sample, with a reagent blank. It can be used to
read an already prepared (manually) solution. The factor for the computation can be either derived
from calibration or set by the user:
Conc. in Sample = Factor x final A
The End Point, Fixed Time, Kinetic and I.R. methods allow, both with single and double reagent,
the use of a special feature called Serum Starter. Normally, during test runs, the arm samples single
or double reagents plus sample. By using the Serum Starter function, the reagents are placed into
the cuvette first and then the sample is placed separately. In this way, the reagents can incubate in
the cuvette for the programmed time, before the sample is added which starts the reaction.
S.S. = Serum Starter, Tr = Delay Time for R1 and R2, Ts = Serum Incubation Time, L = Reading
The way the Reagent Blank and the Reaction’s Dynamics are used is tabulated below:
End Point Reagent blank. Final reaction datum detection (at the end of programmed time for
incubation and reading) and concentration’s value computation.
Fixed Time Reagent’s reading check. Data detection during programmed reading time, absorbance
delta determination (∆A) and concentration’s value computation.
Kinetic Reagent’s reading check. Data detection during programmed reading time,
determination of the absorbance delta per minute (∆A/min.), processing of the linear
regression and computation of the concentration's value.
Initial Rate Reagent’s reading check. Data detection during programmed reading time,
determination of the absorbance delta per minute (∆A/min.), processing of the linear
regression and computation of the concentration’s value.
* During Only Read (End-Point) analyses, the analyzer uses the reactive just to prepare the
reagent blank. The analysis’ procedure requires then to sample at least 300 µl from the final solution
in the sample cups and pour it into the cuvettes for the reading phase. Only single reagent use is
allowed.
For the End Point, Kinetic, Fixed Time, Initial-Rate and End-Point 2 Point methods it is possible
to use single and double reagent methodologies. The Only read method uses only a single reagent,
and the Sample Blank (A) & (B) methods require exclusively double reagent methodologies.
Figure 6 Figure 7
The analysis programming page can be accessed from the main menu (Tests) or from the
specific icon that gives direct access (see Chapter A, paragraph 3., icon n°1 in the Function
Icons Bar) (Fig. 6).
To set out new analyses it is necessary first to create the code (this function is enabled only
in the All Tests) and then to assign the parameters, the standards and the controls (these
are enabled also in the Current Tray). To perform any test it is necessary to move its code
from the All Tests to the Current Tray by using the command Modify Current Tray
(Function Icons Bar, icon n°2). Once the Current Tray is created, it will be possible to
assign a position to each reagent bottle.
Figure 8
Once the code has been created for the relation test (as shown in Fig. 8), it is possible to
program its general parameters and the related mathematical function. In the analyses list
click on the code (the check symbol will be displayed), then select Parameters.
Figure 9
In the parameters window (fig. 9) enter the following information:
Name: complete test name
1st Unit: measurement unit. Clicking on the 2nd Unit it is possible to enter a secondary unit,
with its conversion factor (the analyzer will multiply the 1st unit by the given factor).
Supplementary Factor: The result of the mathematical function will be multiplied also by
this value. This is simply an additional calculation offered by the analyzer.
Normal Range: insert the min. and max. values of the normal range for male, female and
child.
Decimals: it is possible to choose the number of decimals after the point. Leaving the
"Automatic" option the analyzer will follow this principle (floating point):
for values like 0.XXX three decimals
for values up to 9.XX two decimals
for values up to 99.X one decimal
for values over 100 no decimals
To enter the mathematical function select Function
A window divided in two parts will be displayed: one for the calculator and one for the
analyses list (current tray), Fig. 10. The mathematical function can be composed of simple
values and operations or can recall sample results acquired by the analyzer (serum and
urine) on other tests (complex function). To enter a simple mathematical function avail
yourself of the calculator. To enter a complex function, select the code of the test to be
inserted into the function. A small field will appear, where it is possible to select between
serum or urine results for that test. Then complete the function with the needed operations.
To create more complex functions (involving more than one test’s result) it is advisable to
use the parenthesis as for all normal mathematical functions. Ex. For the creatinine
clearance with urine/24h = 900ml [(urine CRE x urine ml 24/h)/(serum CRE x 1440)] the
formula would be: ( [CRE&U] * 900) / ([CRE&S] * 1440).
The button Test Function (Fig. 10.b) is used for checking the relation test result from the
analyzer, based on values given to the tests involved in the function. This option is useful
for verifying the correct use of values and parenthesis in the formula.
The other options (Figure 9) available are:
Save: saves and exits from the window.
Print: prints parameters.
Cancel: exits without saving.
Note. The relation tests can be inserted into the available analyses’ list for the current tray,
even if they have no determined reagent position (refer to paragraph 1.7. Modify Current
Tray). The result for a relation test can be returned only if both the test itself and all the
other analyses involved in the function are present in the current reagent tray.
The first screen shows Primary Parameters, to display the other screens click on the
corresponding tags.
Figure 11
Test methodology: In this field the reaction principle used for the test can be specified (for
example: Jaffè, IFCC, etc.). This option is useful when recalling the tests from the Quality
Control archive, in accordance with different principles, during the function Data
Processing.
Method: This parameter defines the main methodology for the analysis. To program move
the cursor over "6" and select the chosen method. The available methods are detailed in
paragraph 1.2.5. of this chapter.
Figure 12
Kind of process: defines the kind of test’s calibration: "linear", "with factor" or "with curve".
The following choices are available:
Available Methods (Fig.13)
End Point
Kinetic
Fixed Time
Initial-Rate (I.R.)
Sample Blank type (A)
Sample Blank type (B)
Only Read
End Point 2 Points
Sample Blank (A-b)
Sample Blank (B-b)
End Point Starter
Absolute End Point
Figure 13
Section I Chapter C Functions - Analyses Prog. - Ctrls - Calib. Page 18 of 35
linear: This function is used for linear reactions, it requires analytical test calibration to process
computing factor.
with factor: It is used for linear reactions whenever the computing factor is known.
with curve: Non-linear tests, distinguished by:
- Polynomial: a third degree polynomial function is used. It has a very good approximation, but
sometimes it may show anomalies
- Cubic spline: the typical cubic interpolation is used. There is a good connection between
subsequent point couples. Approximation is perfect on single points, but is not flex point free.
- Log-Logit 4 and Log-Logit 5. It is a logarithmic approximation on four or five points, used for
non-linear tests.
- Multi-point: Linear interpolating function for several standard concentrations (max 6).
- Minimum squares: a second or third degree polynomial interpolation is used. It gives the best
approximation to the minimum squares. It is a very simple curve, but sometimes may be distant
from the standard points.
- Line for two points: Used for linear reactions. It requires analytic calibration of the test.
Processes the passing line for two different concentrations. Represents FACTOR (SLOPE) and
INTERCEPT (SHIFT).
- Semi-log: a second degree curve is used, which is function of the concentration logarithm, and
gives the best approximation to the standard points minimum squares. It is asymptotical on the
last point, has no flex points and well approximates the standard points. It may be used for
highly non linear processes.
FILTER: The operator can select the desired filter value for the 1st Filter and the 2nd Filter
(reference filter) from the available filter wavelengths: 340, 380, 405, 436, 480, 510, 546, 578, 630,
700 nm (Figures 14 and 15).
For the tests in bichromatism, click on the "1st Filter" and select the desired filter value from the
cascading window and then go to "2nd Filter" and select the desired filter value from its cascading
window (1st position has empty field).
For the tests in monochromatism, select the desired filter value in the "1st Filter" cascading
window. Since the second filter is not used in this test, therefore select the first position (empty field)
in the cascading window of "2nd Filter". In this case the analyzer will use a "reference filter" only to
stabilize the readings.
Figure 14 Figure 15
Reaction direction: select the kind of absorbance variation to be checked during reaction. The
following choices are available:
(h) Increasing
(h) Decreasing
(h) None
Selecting "None" excludes the possibility of controlling the reaction direction, and in addition no
control is performed on the flags of ABS Limit and out of range reagents. This function is useful
when testing new methods.
Figure 16
Volume µl: enter the reaction volumes for each reagent expressed in µl selecting the corresponding
tag (Reagent #1 and Reagent #2, see Fig. 16). Always bear in mind that there are some limits for
the final solution (reagent + sample) as well as for sample or reagents. See Table 1 at the end of
this paragraph.
Concentrated: this field refers to concentrated reagents. If ready-to-use reagents are used this
option should be disabled. If the program for volume of the Concentrated is enabled, then insert in
the Volume µl text box, the volume of the concentrated reagent that the analyzer will withdraw for
sampling, select the type of diluent to be used: if double distilled water Dilution with water or
dedicated diluent Dilution with solution. Write in the apposite field µl Diluent the volume of diluent
to be added to the concentrated reagent. For example: for a dilution ratio of 1:3 write 100µl for the
concentrated reagent and 200µl for the diluent. The dedicated diluent is considered by the analyzer
as a further reagent and will therefore take a position of its own in the reagents’ tray. If the diluent is
the distilled water, the analyzer will take it from the main reservoir.
Sample: clicking on the button will open the window where sampling parameters for Serum and
Urine can be programmed (Fig. 17 and 18). The Serum card is displayed first. To move between
the Serum and Urine cards, click on the desired tag. The user can enter the following information:
Figure 17 Figure 18
NOTE: for diluting serum samples the analyzer will use the diluent (saline solution) while for
urine samples, the analyzer will use bi-distilled water.
Times: this command allows setting of incubation and reading times. Move the mouse cursor over
Times command and click to confirm; a form appears on a side of the screen with programmable
fields (Fig. 19). The user can then enter the following information:
Figure 19
Indicative volumes
BT1000
BT1500
BT2000 Plus
BT3500
BT3000 Plus
Min / Max Sample Vol. µl 1 / 100 0.8 / 100
Min / Max Reagent Vol. µl 1 / 470 0.8 / 300
Min / Max volume in cuvette µl 280 / 700 180 / 400
Max diluter volume µl 470 300
Min / Max reaction (reag + sample) µl 300 / 700 180 / 400
Table 1
Figure 20 Figure 21
Select the Check Parameters table (Fig. 20 and 21). To set a given parameter, move the cursor on
its corresponding textbox and click to confirm.
The user can enter the following information:
Reagent limit (mABS): this parameter indicates the limit absorbance (ABS) value that is
acceptable for the reagent (maximum for increasing reactions, minimum for decreasing ones) and it
is expressed in mABS. If reagent’s absorbance is beyond this limit, the analyzer will check the
results with O flag (Reactive out of limit). This parameter allows monitoring reagents quality as
well as checking any variation from the specific techniques. The parameter is identical for the serum
and urine.
Note:
This control has the highest priority on all the other check flags and inhibits the automatic
repetition functions. In case of reagent out of limit, the blank will be repeated every time the test
is performed in a run.
Curve Acceptance (%): C.C. = Correlation Coefficient. This is only applicable to kinetic type test
(fixed time, kinetic and initial rate). The programmable values range from 0% to 100%. This
parameter is identical for both serum and urine and indicates the acceptability limit for any data
instability that is detected during programmed reading time. If this value is exceeded, the final result
will be checked with a ± flag (Unstable Sample – C.C.% greater than assigned value).
Test limit (Conc): This parameter is used in all methodologies and it allows verification of the final
concentration of the analyses. It represents a threshold value beyond which the analyzer detects an
out-of-linearity condition (hyperactivity). With Re-run hyperactive check enabled (refer to
paragraph 1.3.6. Automatic re-runs), the analyzer will automatically re-run the test, diluting the
sample as programmed in the serum parameters, in order to bring the reaction into linearity range.
The final result is automatically multiplied by the dilution factor and will be checked with "I" flag (=
Hyperactive Sample – out of Test Limit-).
Initial ABS (mABS): This parameter is used only for the methods Kinetics, Fixed Time and Initial-
Rate. It is expressed in mABS and defines the limit for the total absorbance (reagent + serum)
expected for this test. The first reading of the incubation phase is compared with this value. If the
read value is greater than the parameter, the analyzer will consider that as a possible interference of
serum in the reaction (for example: lipemic serum), thus marking the final result with ~ flag (=
Serum Interference).
Final ABS (mABS): this parameter is used only for the methods Kinetics, Fixed Time and Initial-
Rate. It is the last reading of the reaction expressed in mABS; it indicates the limit (upper limit for
increasing analyses, lower limit for decreasing ones) beyond which the analyzer detects an out-of-
linearity test (hyperactivity). With Re-run hyperactive check enabled (refer to paragraph 1.3.6.
Automatic Re-runs), the analyzer will automatically re-run the test diluting the sample (refer to
Chapter E, paragraph 1.4. Samples) in order to bring the reaction into linearity range. The final
result is automatically multiplied by the dilution factor and will be checked with A flag (=
Hyperactive Sample – out of final ABS Limit-).
Figure 22
After selecting the Secondary Parameters (Figure 22) to program click inside the desired
parameter textbox and confirm.
The user can enter the following information:
1st Unit: Enter the measurement unit in this field. Click on the 2nd Unit to enable it for the second
unit of measurement. Instantly a new textbox will appear where the operator can type in the second
unit of measurement and the conversion factor between the two units. In case of two units of
measurements, the test value is expressed in two results. In the analytical calibrations the 1st Unit
of measurement is used.
1St Unit (Urine): by selecting Urine it is possible to enter a specific unit of measurement and then
the conversion factor between the unit of measurement expressed in serum and that expressed in
urine.
The Factor field is only for urine and represents a multiplication factor. All the information must be
entered in this field, which allows the analyzer to convert the serum units of measurement into those
for urine, to convert the diuresis units of measurement and possibly compensate the different
volume of urine compared to serum (see the note at the end of the paragraph).
Dynamic Blank: If the parameter is enabled, then the analyzer quantifies and memorizes the
photometric drift of the reagent blank by processing only the reagent as sample. After the
determination of the Reagent Delta ABS, this value is then subtracted from the Sample ABS value.
The value of Reagent Delta ABS is then visualized in the "STANDARD" page adjacent to the
absolute value of the reagent. The dynamic blank is only available for the Fixed Time, Kinetics and
Sample Blank A tests.
Number of needle washes: With this command the user can set the number of washings to be
performed after the dispensing of the reagent used for the test. Normally one washing is sufficient,
however in case of highly contaminating tests more washings will be necessary. To set washing
numbers (maximum 9 washings) in accordance with the contaminating force of the used product,
press the up/down arrow keys "v" or move the mouse cursor inside the dedicated box and enter
directly the value.
Additional washes: allows the operator to enter two additional special washes into the sampling
dynamics. These additional washes may be useful when contamination between reagents is found.
The two solutions used are a base to be put in position 24 of the reagent plate and an acid to put in
position 23. The additional wash may be for just the sampling needle (check Only needle) or it can
be for needle and cuvette. In both cases it is possible to select the additional wash to be performed
with one (check Only one wash) or with two solutions: an acid and a base. The needle and cuvette
wash will take place before dispensing the test. The normal water washing of the cuvette will still
take place, it will then be washed with the (or both) additional solution and then rinsed again with
water. In case of double reagents, the needle first wash will take place simultaneously to the cuvette
wash.
If there is no additional solution in the reagent bottle, the test result will be marked with the "W" flag
and the testing of the single analysis will be aborted.
Reagent Blank Timing: This parameter is used for automatic determination of the ABS value for
the reagent. Select, among available choices present in the Reagent Blank timing list (see Fig.
22), one of the following:
(h) Every run: The absorbance determination for the reagent will be performed at every
work start-up.
(h) Every day: The absorbance determination for the reagent will be performed once a
working day (when the first working list of day is started).
(h) Every: The absorbance determination for the reagent will be performed at the time
intervals as programmed into the Hour and Minute boxes. For example, setting "02" hour
and "00" minutes, determination will be performed every two hours. To set the value, press
"v" or move the mouse cursor inside the dedicated box and enter directly the value.
Decimals: If this parameter is used with the Custom, then it sets the number of decimal places that
should be used to represent numerical results of the tests. Alternatively, if the decimal places are
not programmed Automatic, then the analyzer automatically sets the number of decimal places in
accordance with "floating point" algorithm.
NOTE: When the following parameters are used at the same time: Instrumental factor and Shift (in
secondary analytical parameters), External dilution factor and Urine 24/h (in the patient’s data), the
calculation made by the analyzer will be as follows:
[(test result x External factor x Instrumental factor) + Shift] x Urine 24/h
ATTENTION: if the calculation of the result (with instrumental factor and shift) gives a value less
than zero, <NC> (not calculable) will be displayed instead of the result and the associated flag will
be M: Error in the parameters (instrumental factor and shift): By opportunely correcting the
instrumental factor and shift parameters and running the calculation again (with the Correction
function chap. G par. 1.1) it is possible to convert the <NC> result to a valid number.
* The factor will be around 0.1, since the exact relation is given by the relation of volumetric factors,
however the relation vol. S / vol. U can be used as a good guideline.
Note:
Reporting the first and second result when automatically re-running pathological and
hyperactive tests: in case of automatic re-run of hyperactive and pathological tests, the analyzer
displays and prints in real time a compressed report. The report shows the results obtained from the
first and second determination naming them first and second result. However, one should bear in
mind that in the patients archive only the second result is stored, the one obtained after the
repetition. If printing is set in real time in "report" format (see Setup Chapter H, par. 2), the printed
result will only be the second one, just like for the patient archives printing.
Figure 23 Figure 24
The first displayed tables are Level 1 for Known and Unknown controls. To select move
onto the desired tag title and click to confirm (Fig. 23).
Known: To program move the cursor over desired boxes and confirm. Enter Lot name or
number, theoretical value, and low & high limits. Enter Sample position, already set to
controls in the section Setup Analyzer included in the inner ring of samples’ tray.
Unknown: Enter Lot name or number and Sample position. Reserved positions are
those already set in the program Setup Analyzer, which are shared with known ones.
Timed re-run: With this program it is possible to set automatic controls run for a selected
analysis. For each control it is possible to enter the time of automatic execution. Move over
Timed re-run field and check the box.
It is possible to enter intervals of days and hours for automatic controls run (Fig. 24):
upon Date (daily interval): Select the function and set interval days, then enter test
running time (for example 1 08,30 means every day at 08,30 or in any case at start up).
upon Hour (hour interval): Select the function and set the desired interval, hours and
minutes.
Every day or when the preset time expires, the analyzer will automatically alert the user that
there are controls to be run. If reagents and controls are present, then the user can directly
confirm to execute the tests.
View used positions: This command displays the test disposition.
Figure 25
Figure 26
Reagent ABS: each time a reagent blank is executed for the analysis, the measured value is
updated in this window. If Dynamic blank is enabled (subtraction of the reagent photometric
variation, see par. 1.3.3. Primary Analytical Parameters and following paragraphs) the measured
reagent ABS value is displayed, plus the variation determined during reading of the blank.
% from last Calibration: parameter which checks the percentage between the executed and
previous calibration. It compares the determined factor with the memorized one. After a variation
above the programmed limit, a warning is given and the previously memorized factor is not
changed.
View used positions: opens a single box to represent the position of tests in relation to the
sample tray.
Enable Auto Adjust: this parameter enables or disables automatic modification of the tests
results if another calibration is executed when running patients. The user must be enabled to the
access level (by password) to modify this parameter.
Last standardization: display box for the date and time of the last test calibration performed. By
double clicking on the box it is possible to view the data of the previous calibration, factor,
concentrations and absorbance.
Timed re-run: parameter used to program automatic calibration execution. Once the
programmed standardization time has elapsed, the analyzer sends a warning message and if the
reagents and standards are present, calibration can be directly executed. Enter the
standardization time by enabling the check and program the intervals in days and hours:
By Date: select the function for programming the interval days, then indicate the test
execution hour (e.g. 1 08.30 means every day at 8:30 or each time the analyzer is turned on).
By Hour: select the function and program the desired time interval, in hours and minutes.
Print: command for printing the programmed parameters.
Save: command for memorizing and exiting.
Cancel: program for exiting without memorizing changes.
Non Linear analyses require from 3 to 6 standards. If the process type is Multi Point the number to
enter in the Number of Samples box varies from a minimum of 2 to a maximum of 6. In the
analyses with Log logit 4 & 5 curve, programming is the same by the required positions are 4 and
5, respectively.
Select the number of standards to be used to construct the curve. The fields for entering the position
and concentration of the various standards appear automatically. The values in the ABS boxes are
automatically updated during the calibration phase, if known they can be entered by the operator.
Programming is similar to that for analyses with factor, but here automatic standard dilution is also
available.
To use the standard pre-dilution function program the positions of the standards and enter the
calibrator concentration (the most concentrated point of the curve) at the first pre-selected position.
Then click on the Automatic Dilution box. Three new fields will open:
Figure 27
Dilution: sets the dilution relation. The analyzer will automatically calculate and update the scalar
concentrations starting from the highest concentration value already present in the fields.
Place the cup with entire standard on the sample tray in the assigned position, plus a number of
empty cups equal to the subsequent standards. The serial dilutions used to build the curve will be
prepared in these cups.
Dilution with solution: used to select whether to dilute the sample with physiological solution
(located in the specific test tube) or with bidistilled water taken from the external tank.
Use Zero Point: used to automatically reset the concentration of the lowest point of the curve to
zero. During the predilution phase of the standards the analyzer will dispense the pre-selected
diluent (physiological or water) in this position.
For all the tests with calibration curve, the analyzer will warn the operator if samples (patients) have
results above or below the calibration curve with a flag (below curve "<" and above curve ">") next
to the result. It is possible to select automatic re-running for samples outside the curve in the control
parameters (see par. 1.3.6 Automatic repetitions). When the absorbance of the least concentrated
point of the calibration curve (or point with 0.0 concentration) is negative, it will be automatically set
to zero, in order to prevent false results, for example concentrations with a minus sign.
It is possible to normalize the memorized calibration curves, using a single calibration point (see
below).
Use serum Pre-dilution: if in the sample primary parameters (par. 1.3.3.) a pre-dilution ratio has
been set, it is possible to perform the standards pre-dilution with the same ratio as for the sample.
Graph: command for displaying the interpolation graph of the memorized curve. The curve and data
are represented on the graph display page.
Figure 28
Figure 29
Creating a profile: click over New button: the Profile Name textbox will appear. Enter the
name for the profile and click on Analyses: this will open a window where it will be possible
to select the analyses for the profile. Click "Save" to store the selected analyses (Fig. 29). It
is possible to enter in the Code for Bar-Code field a numerical code. The analyzer, when
reading the bar-code labels of Patients, will recognize it. This code is used for completely
computerized acquisition of the analyses assigned to the patient.
To update an existing profile, select it from the list and click on Modify, and then proceed
as outlined previously. To delete an existing profile, select its name and press Erase,
confirmation is requested prior to erasing.
Attention: during the patient acquisition, only the analyses present on the tray are
displayed for each profile.
Figure 30
The function Create/Modify current reagents' tray creates the list for the reagents placed
on the tray. It can be accessed from the Tests main menu or from the specific icon that
allows direct access.
Into the window (Fig. 30) the "All tests" list (Available) is displayed and adjacent to it (In
Tray) the tests for the current tray are listed.
To create the reagents’ tray list, select one or more (CTRL+mouse for multiple selections)
tests from the left window then transfer them with arrow commands " " (move single test or
selection) or " " (move all available tests).
To remove from the current tray list select and transfer codes with commands " " (single or
selection) or " " (all available). Once tests are transferred, the analyzer automatically
assigns the positions and the type of bottles, but the user can modify both according to his
needs.
To modify, select the desired test in "In Tray list" and then move the cursor in Position #
textbox. Now enter directly the number or use up/down arrow keys "v" to scroll. Bottle size
can be selected by checking hLarge or hSmall. There is also a field for selecting the
volume of available bottles.
In case of Double Reagents or Concentrated, to be diluted with solution, positions and
bottles’ type are displayed for each product. It is possible to use the same reagent position
for several analyses.
The creation of the current reagents list is automatic when the Bar-Code option is enabled
(refer to Chapter I).
The Relation Tests can be entered in the analyses tray. They are placed at end of the
generated list and no physical position is assigned to them.
Save: Memorizes data and exits.
Exit: To leave (exit) the program without saving.
Print: To print data in the current tray.
NOTE: for the I.S.E. module specifications, refer to the dedicated chapter
(Chapter L)
GENERAL INFO
Operating Mode: Random access
Methods: Tests for Clinical Chemistry and Immune-Chemistry
Test Mode: Routine, Batch, Emergencies (STAT), Profiles
Tests in memory: 500 single or double- reagent + unlimited Relation Tests
Test Re-runs: automatic or on demand
Calibrations and Controls: automatic or on demand
Automatic Profiles: automatic execution of related profiles or on demand
Quality Control: 3 known levels and 3 unknown levels
Remote diagnostic: Via Modem (optional)
Maintenance: Automatic program
PERFORMANCES
BT1000 BT1500 BT2000 Plus BT3000 Plus BT3500
48 reagents + 48 refrigerated 48 refrigerated 80 refrigerated 80 refrigerated
Tests on line: relation test reagents reagents reagents reagents
+ relation test + relation test + relation test + relation test
direct reading direct reading of direct reading of direct reading of direct reading of
of 25 cuvettes 32 cuvettes in 25 cuvettes in 34 cuvettes in 45 cuvettes in
Measurement:
in optical optical glass optical glass optical glass optical glass
glass
78 total 78 total 78 total 78 total 78 total
positions positions; positions positions positions;
52 for 62 for Samples 52 for Samples 52 for Samples 62 for Samples
Samples & & STAT, & STAT & STAT & STAT,
Samples Tray:
STAT 16 for Standard 26 for Standard 26 for Standard 16 for Standard
26 for and Controls and Controls and Controls and Controls
Standard and
Controls
1 for Samples 1 for Samples 1 for Samples 2 for Samples 2 for Samples
Sampling arm:
and Reagents and Reagents and Reagents and Reagents and Reagents
2 distinct 2 distinct 2 distinct
barcode barcode barcode
scanners for scanners for scanners for
Bar code scanner: Not available Optional positive positive positive
identification of identification of identification of
samples and samples and samples and
reagents reagents reagents
I.S.E. Module: Not available Not available Not available See Chapter L See Chapter L
Sampling cycle: 18 seconds 14.5 seconds 14.5 seconds 12 seconds 10 seconds
Analytical Up to 200 Up to 250 Up to 250 Up to 300 Up to 360
Throughput: test/hour test/hour test/hour test/hour test/hour
BT3500 TIME USED WASHING SOL. (approx) USED DEDICATED SOL. (approx)
Wash with water 5’ 200 ml
Wash cuvettes 7’ 250 ml 15 ml
Extra wash cuvettes 11’ 500 ml 15 ml
Zeroing on water 6’ 200 ml
Sleep mode wash 5’ 200 ml
FCC Function 15’ 300 ml 15 ml
Cuvette single wash 2.5 ml
Needle single wash 2 ml
Consumption per test 4.5 ml
BT1000 & BT2000Plus TIME USED WASHING SOL. (approx) USED DEDICATED SOL. (approx)
Wash with water 5’ 200 ml
Wash cuvettes 7.5’ 250 ml 15 ml
Extra wash cuvettes 11’ 500 ml 15 ml
Zeroing on water 6’ 200 ml
Sleep mode wash 5’ 200 ml
FCC Function 15’ 300 ml 15 ml
Cuvette single wash 6 ml
Needle single wash 2 ml
Consumption per test 8 ml
NOTE: stated times and liquid consumptions should be considered only as indicative as they may
vary in different conditions.
Operating Limits
The instrument cannot guarantee the preceding performance specs in the following conditions:
1) Ambient conditions beyond the specified range.
2) Use of non-conformant clinical chemistry products such as washing solution, distilled water, and etc.
3) Maintenance schedule and expiry date ignored.
4) Use of non-original spare parts and consumables.
The manufacturer does not guarantee the correct instrument. In case of implementation of unanticipated
methodologies. Consult your nearest sales/service office or factory for the use of different methodologies.
NOTE:
Figure 1
This function is accessed either by pressing F10 key or by clicking on the specific icon. It
helps the user to correctly position the reagent bottles, as programmed in the current tray.
The reagent tray is divided into sectors, identified by the letters A, B and C for BT1000,
BT1500&BT2000 Plus, while for BT3000 Plus and BT3500, the letters are A, B, C, D and E.
Each sector has 8 positions. The screen displays the representation of 8+8 bottles (Figure
1). The analysis codes of large bottles are displayed on the lower positions, while the upper
positions indicate the codes used for small bottles. By clicking on the Special reagents, the
diluent and I.S.E. , where available, reagents volume status are displayed.
The symbols + or XXX<2 can be displayed inside the code boxes (fields). The symbol +
indicates that the position is used for many analyses, while the symbol XXX<2 indicates the
position of second bottle pertaining to the double-reagent analyses.
In the field SECTOR the belonging group is shown, and the default choice is "A". To
change group click on the left and right hand buttons
NOTE: if the bar-code function on reagents is not enabled, when using the “Remove”
option (both for single bottle and for Sector), no functional control is performed: the
existing volume and test code are not removed from the view volumes window.
In case the bar-code on reagents is enabled, when removing a reagent with the
"Remove" function, the analyzer will perform a scan of the position (or the sector) to
verify that the reagent has been removed. When closing the View volumes status
window, the analyzer will perform a second verification scanning and then will move
the removed test code from the on-line tray to the global list.
Check volumes
This option checks, on user’s demand, the volume contained in all the bottles that are
placed on the tray. Click with mouse on this command to confirm.
Special reagents: command for checking the volumes of reagents and washing solutions
for the I.S.E. module plus the diluent solution for the samples. With the Check volumes
command the analyzer checks the volume contained in all the bottles. By clicking with the
right mouse button, a window opens with the Insert bottle and Check volumes command,
similar to those explained above (see Fig. 1).
Print
Performs a printout of the reagents status, with volumes and positions.
Section I Chapter E Operating Procedure Page 3 of 20
Volume’s information
By clicking on the each analysis code, the volume of the reagent contained in the bottle is
displayed as well as the number of tests that can be performed with it (Figure 2). For
various tests in the same position, they will be listed individually. The count of the
executable tests is made by single analysis, as if it was present alone in that given position.
The Real samples field refers to the maximum number of samples which can be executed
for the test when one of the reagents has a lower volume than the other. In this case the
reagent with the lower volume determines the maximum number of samples that can really
be executed.
Figure 2
Figure 3 Figure 4
The Run Standards and Run Controls functions are available from the Tests main menu
or through the specific icons that allow direct access.
The displayed analysis codes belong to the list generated in the Current tray list. Only
codes with programming, even if incomplete, are displayed on the controls page. In this
case the un-programmed levels will be displayed, even if not enabled. The entire list of tests
present in the current tray is displayed for the standards (with the exception of relation
tests).
RUNNING STANDARDS
Standards’ calibration can be run either on command or automatically at pre-determined
time intervals (refer to Chapter C, paragraph 1.5. Calibrations). Both choices can coexist.
The commands are Immediate Standards and Timed Standards (Fig. 3).
Immediate Standards: Once the button is clicked a list of codes appears, select the desired
tests and run by pressing Run. With Select All or Deselect All commands, it is possible to
select or deselect the whole list. A message will ask the user whether the calibration
standards are already present in the tray or not. If the samples are already present, click Yes
and calibration procedure will automatically start. Otherwise, if calibration samples aren’t
already placed on the tray, click No; in this case a procedure will guide the user through
samples’ insertion. By clicking over sample’s position, the tray moves itself to accommodate
cup’s insertion. Once the necessary cups have been inserted, it is possible to run the
calibration.
Timed Standards: Only the codes with programmed times are enabled. After selection of tests, the
calibrations can be run. In this case, the interval of the automatic calibration starts when tests are
run. In case the calibrations aren’t run, then the time count of calibration’s interval starts from the
moment the selection was made. Once the automatic calibration time has elapsed a message
appears on the screen asking the operator if the tests need to be run. If the standards and reagents
are on the tray answer yes. At this point the automatic calibration time restarts.
If the message is not answered or a negative answer is given, the calibration time count starts
again. The previous calibration remains in the memory. If the timing expires while the analyzer is in
standby, it will be automatically moved 10 minutes forward.
Figure 5
NOTE:
Point the cursor on the desired option and click to confirm.
Figure 6A
Figure 6
Group: Select the group (Man, Woman, Child) for correct reference with normal values
range.
Type: It is default set to Serum. The sample type (Serum or Urines) is selected here. If
Urine is selected, then the volume of diuresis (in the 24h) is requested. This is required for
processing data acquired with automatic calculation on 24 hours. If this processing is not
required then leave the value at zero "0".
Assigned Group (Routine or CTRL Routine): The default setting is Routine. It is used for
selecting the category (Patient or Control Serum) during sample programming. Selecting
CTRL Routine the type (Known or Unknown) and levels (Level 1, 2, 3) must be specified.
Position: Displays the first free position from the available positions. To modify this field
use horizontal arrows ⇐ ⇒ or type in the desired position. Do not modify to accept.
Code: It is the identification number assigned by the user to the patient. The user can also
enter the code of a patient saved in the work list, even if in execution. In this case, a
message asks the user to confirm patient’s data cloning. In case of affirmative response, all
the data relevant to the patient is instantly displayed and is linked to the current position.
The cloning of a patient’s code allows the user to obtain one report in case different
samples are used. If this option is not used, then separate reports are obtained.
Duplicate patient: By clicking on the icon, it is possible to create a worklist with the same
profile (Autobatch) or else a list with sequential codes. When the patients are entered
using the duplication method, their codes may be assigned by the analyzer, or it may be a
progressive number. In the case of progressive number, the operator must enter the first
code to be used.
Surname, Name: Enter patient’s personal data.
Draw Date: System date is automatically displayed. To modify, move mouse cursor on
textbox, click and edit.
Note: Additional information to be added to the report.
External Dilution Factor: By default set to "1". It allows analysis determination on
externally diluted samples. Enter in this field the external dilution factor ratio used in sample
preparation. Final result is multiplied by the inserted ratio.
CAUTION!
IN THIS CASE THE PRE AND POST DILUTION FACTORS OF TEST PARAMETERS
WILL NOT BE TAKEN INTO CONSIDERATION.
NOTE:
If a hyper-activity parameter value is surpassed (indicated by an appropriate flag)
during determinations of externally diluted samples, the Automatic Re-run is not
performed.
Test: Generates the Analysis List. Select each analysis to be performed on the sample.
Profile: The stored Profiles list (Fig. 7) is displayed through this command (refer to
Chapter. C, paragraph 1.6. Creating Profiles). Two acquisition modes are available. The
first one requires a double-click on profile’s name. The second mode, after choosing the
profile with one click, requires confirmation by activating Select.
The analyses programmed in this way can be modified. To add or remove tests, it is
necessary to enter in the screen "Select tests" and confirm by clicking on the textboxes.
With "Deselect", it is possible to delete an already selected profile.
Figure 7
Delete: Cancels the programmed patient or the analyses of an already programmed (and
saved) patient. Confirmation is requested.
Save: Saves patient’s data and the associated analyses. With this command test execution
is delayed.
NOTE:
In the routine programming, it is possible to acquire a greater number of patients
than the available number of positions in samples’ tray. All the patients acquired with
no associated position are saved and displayed in the extra patients list and can be
transferred to the main list on user’s demand (refer to paragraph 1.5. Work Lists).
Run: This command immediately starts the execution of the programmed patient. The
sample plate adjusts itself to match the position assigned to the patient, and a blinking red
LED indicates the position for inserting cup or primary tube. If patient code is missing or no
analyses have been selected then this command cannot be activated.
Figure 8
New Entry/Controls:
Once the icon "Controls" is selected, the list of control positions is displayed (Fig. 9).
Controls acquisition frame is displayed by activating New Entry command or with aclick on
a given position. A window identical to the one displayed in Routine appears but without
the patient fields. Bear in mind that the tray positions reserved for controls are the ones
assigned in the Analyzer Setup (Chapter H, paragraph 2.). An appropriate screen
message alerts the user when a wrong position number is entered. Patients acquired as
"Controls" can be saved as described in "Routine", and are executed afterwards. All the
acquired controls without assigned position are saved and displayed in the temporary list
Extra Patients (Control), from where they can be transferred on user’s demand (refer to
paragraph 1.5. Work Lists).
Figure 9
ATTENTION: when programming a batch, it is necessary to be sure that all the selected
positions are free and not already programmed in the routine work-list. When "Run" is
selected, the analyzer will ask confirm that the positions are free.
"Are you sure that the selected positions are all available?"
Answering "Yes", the batch will be run, answering "No", the run will be aborted in order to
allow the operator to verify if the positions in the routine work-list are available or not.
If the operator runs a batch in which some of the selected positions are not available, the
analyzer will skip on those positions and will keep the already programmed patients (in the
same status these were before running the batch). The positions of the batch that have
been skipped will not be considered at all, as if these were not programmed from the
beginning.
Figure 10
Figure 11
The Work Lists can be accessed through the menu "Patients" → "Insert Routine/STAT" or
directly using its proper icon. The screen displays the "Current Tray (Routine)" in the center
and the "Extra Patients (Routine)" on the right. During the working phase, it may be useful
to display also the "Re-run" worklist.
Click on the Routine, STAT, Control and Standard buttons to view the corresponding
work lists. For "Control" and "STAT", as for the patients, the screen displays the "Current
Tray (Routine)" list and the "Extra Patients (Routine)" list. It is possible to run controls and
calibrators even during the determination of patients. Thework-lists show the position
number and test code: the samples being run are marked in red, the free positions in green,
the samples which are programmed but in Stand By are marked in blue. If there is a lack of
serum or reagent in the Performed Patients List they are marked in yellow. The patient
codes have Italics characters for cloned samples and are underlined for determinations and
repetitions. The characters are yellow for data being processed. The samples located in the
Extra Patients List are graphically indicated in blue.
Work Lists are used to display the entered patients’ codes or to verify the samples’ state on
the tray (Fig. 11)
Print: Prints the partial (for selected items) or total samples list.
Scan tray: Allows positive identification and saves present samples on the tray. It is
subdivided into the following two functions:
All: The tray performs a rotation scan to make a positive identification, and saves
all the samples (codes) in the sera tray.
Single Position: Allows positive identification and saving of only one single code.
The analyzer requests the desired position and the tray accordingly positions itself
for sample’s insertion. Makes one rotation for reading the present code.
Scan tray and run: Performs reading rotation as before, but runs the tests immediately.
NOTE:
In patients’ bar-code printing protocols it is possible to add Profile Number, which
provides total automation in patient acquisition (refer to Chapter C, paragraph 1.6.
Creating Profiles and Chapter I, paragraph 1. Bar-code and related functions).
During bar-code reading, the analyzer provides a list of likely errors that occurred. In
this case the reading can be repeated by re-activating the command.
1
2
Figure 12
In the Performed patient window the following information are displayed:
group which the sample belongs to.
sample type.
already performed tests (the test graph can be displayed by clicking on the test code).
remaining tests (to be performed).
To re-run, the desired patient code must be transferred to Current Tray List and then run
again. Confirm with a single click on the position number, confirmation is requested
before transferring. If the answer is positive, then the screen “Select Repetition Position”
is displayed. If available the previously used position is shown otherwise the first vacant
position is presented, modify if necessary. Once the position is confirmed or modified,
Registry Situation with related analysis is presented. Deselect the analysis that should
not be repeated, add new tests if needed. Once programming has been terminated
confirm with command "Run" to run the sample or "Save" for memorizing.
NOTE:
Confirmation is requested in all the patients’ work lists, to perform Codes Transfer
Commands. The analyzer verifies the availability of positions in the samples tray list
and eventually prompts the user about the impossibility to complete the task.
Figure 13
Figure 14
♦ Run All Pending Patients:
A sole command for running the already acquired patients and the partially processed
patients (because of an interruption during tests execution). The analyzer will continue to
process suspended patients. Confirmation is required.
♦ Repetition for Analyses:
This command re-runs test for samples. First the selection of the desired analyses codes is
required and then the confirmation. The analyzer automatically searches for the samples
which had already undergone determination of selected analytes, and performs the newly
assigned work list and then updates patient reports with new data obtained from the
repetition.
♦ RS 232:
This function is used for transferring data from the analyzer to the host computer. Data
transfer can be automatic if enabled in the Setup. If it is not enabled, then the data transfer
occurs on user’s request through the command Accept Result to be sent. Confirmation is
required. The function Delete Result to be sent allows deletion of the data to be sent to
the host computer; confirmation is required (see also Chapter H, paragraph 2. Analyzer
Setup).
♦ Clear Patients’ List:
This command allows deletion of the previously acquired patients list. Confirmation is
required. It deletes the whole list.
NOTE: if cuvettes are not properly washed at the shut-down, at the following start up
the analyzer will ask for the cuvettes extra wash (with acid solution). Performing the
normal cuvettes wash (with the cuvettes washing solution) will not prevent the
analyzer from warning again that the extra wash is needed.
Conditions are:
a. If no test has been performed before the shut-down, at the following start-up of the program, no wash
message will appear.
b. If no test has been performed before the shut-down and the shut-down wash has been started but it did
not complete correctly, then at the following start-up of the program, the analyzer will warn the operator that
the preceding wash was not correctly completed.
c. If tests have been performed and the shut-down wash was not performed, at the following start-up of the
program, the analyzer will ask for the Extra wash cuvettes and will warn the operator that the preceding
wash was not correctly completed.
NOTES:
1) Having performed a test: it means having performed either a single test with reagents and sample or any
procedure involving colored solutions, such as the FCC.
2) The analyzer asks for the Extra wash cuvettes as it does not know how long the solutions were left inside
the cuvettes before washing them.
The analyzer provides two other modes for interrupting its operation:
1) SLEEP-MODE
This mode can be manually activated, or it starts automatically when the instrument is left
inactive for more than 30 minutes. The Sleep-Mode automatically performs the wash and
fill up of the cuvettes with bi-distilled water and remains idle (waiting for user’s commands
for immediate operation).
2) LOG-OFF
The "Log-Off" mode represents a partial turning off of the analyzer. It disables some
devices: halogen lamp of the photometer, cuvettes thermostat and drive motors. This mode
is used for energy saving.
The Log-Off mode is utilized for programming automatic turning on at a desired date and
time. The instrument will remain in a stand-by condition and it will automatically turn on 30
minutes before the programmed time. The turning on in anticipation allows the analyzer to
reach steady state thus allowing immediate operation at the programmed time.
To exit ahead of time from a suspended activity, click on the left or right mouse button and
press the Exit button on the window that appears. However, in this case it is necessary to
wait for the devices to become operational.
NOTE
It is not advisable to keep the analyzer ON for more than one month as this may
cause problems with Windows internal counters.
CAUTION!
If the SHUT DOWN procedure has not been observed, then do not ever stop the
analyzer by turning off the main switch. This may cause irreparable loss of data in
the archives and damages to the operative program.
Section I Chapter E Operating Procedure Page 17 of 20
1.7. ACCESS PASSWORD
To comply with the European law on privacy (processing of sensitive data) enacted with
Italian Legislative Decree no. 196 of 30/6/2003 passwords have been implemented for the
analyzer. This makes it possible to keep a record of the activity of each authorized operator.
When the analyzer is installed or first used, the Administrator or lab manager must assign
each operator with a Username and password combination, associated with his own access
level to the program.
The first window that appears is dedicated to the Administrator (a manager who takes care
of archiving as well as password management of the users who have access to the
analyzer).
The Administrator needs to enter the following in the Username field: ADMIN
The Administrator needs to enter the following in the Password field: Administrator
Figure 15
After pressing the Logon button, a window will open where the Administrator enters his new
personal password.
Figure 16
The Administrator password does not have an expiration date, while those assigned to
operators need to be renewed every three months.
Figure 17
Each level allows access to normal analyzer operations (acquisition and running of patient
lists, Calibrations, Q.C. program and Population, etc.) plus some specific functions that
would otherwise not be available. Access to the patient archive is allowed by putting a
check in the specific box.
To be able to allow a user to have an access level other than 0 it is necessary to know the
system password that allows access to the same level. This is requested after selecting a
level.
The system passwords can be changed in the analyzer Setup. Access is only allowed to
the third level.
ATTENTION: if the new system passwords are forgotten, it is necessary to format the
hard disk and reinstall the program. In this case any unsaved data will be lost.
Biotecnica shall not be held liable for system passwords that are changed by the
user.
NOTE: the users password MUST be at least of eight characters. It is advisable to use
alpha-numeric passwords. Avoid using 8-times repeated characters such as
YYYYYYYY or 33333333.
It is advisable to test the password every time a new password is programmed.
CHAPTER F
1. QUALITY CONTROLS Page: 2
1.1. Inserting/modifying controls Page: 2
1.2. Data management Page: 4
1.3. Displaying and processing by lot pairs: Juden graph Page: 6
1.3.1. Westgard Graph Page: 7
1.3.2. Daily Chart Page: 9
1.4. Additional Functions Page: 10
2. POPULATION Page: 11
2.1. Analysis Selection (How to run a Query) Page: 12
2.2. Principal statistics formulas used in Population module Page: 16
2.3. Inserting external analyses Page: 18
2.4. Other menu functions Page: 19
3. PATIENTS’ ARCHIVE Page: 21
3.1. Selection (How to run a Query) Page: 23
3.2. Patient’s report Page: 25
3.3. Printing Reports Page: 27
3.4. Other menu functions Page: 29
NOTE:
This is an external program used to enter, change and process quality controls. The
program can process data from the analyzer (controls run in routine or dedicated positions)
and from other instruments (with the Insert / Modify Data function).
NB: due to the large dimensions that the archive can reach, it is advisable to run a
backup at regular intervals, even monthly.
It is advisable to use the “Export Data” function in the FILE menu to export the
archive in CSV or Fixed length format (see par 2.4 OTHER MENU FUNCTIONS).
Once the archive is saved into a different location, please delete the internal archive
to avoid the archive itself to crash.
Figure 1
Figure 2
Figure 3
To obtain data processing it is necessary to provide the analyzer will all the information
related to the control: Analysis, Lot, Method, Control type – Known/Unknown – and
Level.
If the All option is left in the Lot and Method fields, the search will be done for all the lots
and all the methods relative to the test selected in the Analyses field. In this condition the
Range and Westgard Decision values will not be displayed (fig. 3a).
Figure 3a
Make all the selections necessary for processing the data, then press the Search button.
The results will be displayed as shown in figure 3. The data are ordered by date and time.
Out of range controls are indicated with an asterisk.
To delete a record, it must be first selected with the left mouse button, then it can be deleted
by pressing the right mouse button. This is possible only if the search is Daily and not Total.
When the search is run on unknown controls the range and Westgard classes are not
displayed.
Deleting data: see fig. 3 and 3a. After having performed a daily query, it is possible to
delete one or more control values. To delete a control, first highlight it, then right click on it
and confirm.
After selecting the key parameters Analyses, Lot, Method, Type (Known/Unknown) and
Level, data processing and visualization is performed. The controls are ordered by date
and only in case of known controls the Out of limit condition is indicated. Refer to Figure 4.
This function relates two different levels for the same lot displaying distribution of controls
within the limits of lots.
Figure 4
By clicking over a value plotted on the graph, the information relating the pair of values will
be displayed.
The Westgard graph provides a global vision of a given lot by plotting data on a diagram
having the origin at 0 line representing the lot mean value, calculated as (lot min + lot
max)/2, which usually corresponds to the lot theoretical value. As division, are reported
values such as Mean±1S ±4S (see Westgard table in Figure 5). All data within the given
range will be displayed with a green triangle while the out of range data will be plotted using
red squares.
Figure 5
By clicking the mouse over a given value in the graph, its information will be displayed (fig.
6). Click on the "Print" button to print the graph.
Figure 6
Class C (2-2S): Two consecutive results exceed mean by 2S in the same direction.
Class D (R-4S): Difference between two consecutive results is higher than 4S and at
least one result exceeds mean by +/- 2S.
Class E (4-1S): Four consecutive results exceed mean by more than 1S in the same
direction and at least one result exceeds mean by +/-2S.
Class F (10x): Ten consecutive results are all in the same direction of the mean value
and at least one result exceeds the mean by +/- 2S.
Classes are controlled from F to A. The classes are mutually exclusive, that is, if a given
value is mapped to one class then it can't be part of another class.
Example:
2 E classes means that 5 consecutive results exceed Mean by more than 1S in the same
direction and at least one result exceeds mean by +/-2S; alternatively two groups of 4
consecutive results exceed the mean by more than 1S in the same direction and at least
one result exceeds mean by +/-2S.
Figure 7
By clicking the mouse over a given value in the graphic, its information will be displayed.
Click "Print" to print the graph.
Figure 8
Figure 9 Figure 10
The FUNCTIONS menu contains the following:
Export Data: Saves memorized quality controls by selecting a particular "Method",
"Analyses", "Lot", and "Date". If "All" is selected in the above-mentioned fields then all
controls will be memorized. Refer to Figure 10. It is also possible to export the QC data in
CSV (comma separated values) or Fixed length formats, compatible both with Word or
Excel kind applicatives.
NOTE: the use of this function is very important to have constantly updated archives
in a hard disk different from the analyzer’s.
Once the *.csv or *.txt file has been created, it can be opened with Excel or Word.
First open the appropriate program (both programs will open both kind of files, but
the easier way is to use Excel for *.csv and Word for *.txt files). Then select “Open
file” and in the “open” window, select in the field “File of type”: “all files - *.*”. Click
twice on the file you want to open.
Import Data: Overwrites the actual stored data with the imported data. CAUTION: It is not
possible to restore overwritten data.
Delete Data: it is possible to delete records in the archive by Date, Method, Analyses, Lot
or erase the whole archive (Figure 9). CAUTION: It is not possible to restore deleted
data in the previous "Delete Data" command.
- Reindex Data-Base: function used to reorder the Quality Controls archive.
- Close: closes the Q.C. program.
The DATA menu contains the functions explained in the paragraphs above.
Figure 11
Figure 12
The Population module manages and displays graphs as well as data, and computes
statistics on data of all the analyses performed by the instrument.
N.B.: due to the large dimensions that the archive can reach, it is advisable to run a
backup at regular intervals, even monthly. It is advisable to use the “Export Data”
function in the FILE menu to export the archive in CSV or Fixed length format (see
par 2.4 OTHER MENU FUNCTIONS). Once the archive is saved into a different
location, please delete the internal archive to avoid the archive itself to crash.
The main functions are:
Display and data acquisition from updated analyses file.
Update internal archives.
Generate dynamic query that allows to sort and display data by analysis, analytical
method, results’ range, group, type and date.
Statistical operations: display number of run tests, mean calculation, standard deviation,
variation & correlation coefficients, variance, deviance, angular coefficient and known
term of the minimum square line.
Display data graphs: Trender (data with fitting line), L. Jennings, histograms with base
zero and statistical (mean value represents the base).
Printout of total and partial data, graphs, and statistics.
Figure 13
To perform any query it is necessary to select an analysis from the Select Analysis list
(Fig. 13). Once selected all existing methods associated to the analysis (Select Method)
are displayed. It is possible to select among the available methods by clicking on the check
box. One can simultaneously enable the search for one or more groups "Group" (Man,
Woman, Child) or Test Type (Serum, Urine, Relation). Moreover it is possible to limit
search within two dates (Date range) or according to a given data range (Results range).
Once the all query criteria have been selected, press the Search button to display the data
and statistics referred to it (Fig. 14). This page shows the statistical processing for the
query. They are also present on the pages for graphic processing (Diagrams)
Figure 14
The query data can be printed (Print Preview) in three different formats:
- Only values
- Only statistics
- Values and statistics
Once the selection is made the print preview page opens. To print, press the printer icon.
Figure 15
By clicking on one of the keys related to diagrams it is possible to view one of the graphs
listed below.
Figure 16
By clicking on Data Sequence (Fig.16) key, the data sequence is displayed.
Figure 17
By clicking on Trender button, data sequence is displayed together with its related minimum
square line (Fig. 17); in the lower part of the graph the equation for the line is shown.
L. Jennings Graph
Figure 18
By clicking on L. Jennings button, L. Jennings graph is displayed for the selected data
(Fig. 18).
Figure 19
Figure 20
By clicking on Statistic Histogram button, the histogram for the selected data with respect
to the mean value is displayed. (Fig. 20).
♦ Mean:
♦ Standard Deviation:
SD: is a quantity that measures the spread of data across its mean value. If data is mostly
located near the mean SD assumes a small value, otherwise a large value indicates large
data spread.
n
DS =
Σ (Xi – X)
i=1
2
n-1
♦ Variation coefficient:
CV%: is computed as the ratio between mean square error and arithmetic mean. CV% is a
relative quantity and independent from the measurement unit used.
DS*100
CV=
X
Σ XY-nΣxΣy
a=
Σ X2 - n(ΣX)2
b= ΣY-aΣx
♦ Correlation Coefficient:
Σ[(Y-Y)*(X-X)]
CC =
Σ(X-X)*(Y-Y)
♦ Variance:
[ X* X]
ΣΧ2 - Σ nΣ
V=
n-1
♦ Deviance:
2
(Σ X)
D =Σ X2 - n
The median for N even elements, is the { X(N/2) +X[(N+2)/2] }/2 element.
Ex.: be given the following 8 elements set
1, 2, 12, 24, 26, 45, 45, 46
{X[4]+X[5]}/2 = (24+26)/2 = 25
median is 25.
By comparing the median and the arithmatical mean, one can assume the existence of a
measurement error or an asymmetry in the distribution function, in case these two
quantities differ greatly.
Figure 21
It is possible to store in the analyzer’s memory results of other analyses not performed by
the analyzer. These data will be saved into the archive and it will be possible to display
statistics as well as analyses results.
The input screen (Fig. 21) shows the following fields:
Analysis Name, Analytical Method, Result, Date, Group and Test Type.
To insert a series of consecutive values for the new analysis, the results field should be
programmed last. Then enter the results by pressing Enter on the keyboard (or the Accept
button) to confirm each value.
By pressing the Exit key the external analysis insertion window closes and the entered data
become available for statistical processing.
Data entry is case sensitive, meaning that an analysis name written in capital letters (YOU)
is different from the one written in lower case letters (you) and is different from the one
written with initial upper case letter (You).
Figure 22
FILE MENU
Backup: creates a backup copy of the executed query. The backup
copy can be saved on a floppy disk or the hard disk.
Restore Backup: used to restore the backup copy to its original
position.
Export Data: this function allows exporting data in CSV (comma
separated values) or Fixed length formats, compatible both with Word
or Excel kind applicatives.
UTILITY MENU
Insert new Record: see the paragraph above (par. 2.3
and fig. 21)
Setup: opens the printer setup window (see also Ch. H
Analyzer Setup, par. 2)
Format floppy disk: used to format a floppy disk.
Report with grayed lines: used to select whether to
print the reports in "easy reading" format. Easy reading
printing contains light gray lines alternated with lines
the color of the paper.
DELETING MENU
Delete Record(s) selected: it is possible to highlight several values in a query by holding
down the CTRL key while selecting various results
with the mouse cursor. These values can be
deleted with this command.
Delete analysis data: deletes all the data related
to the selected analysis and executed query.
Selected analysis data that is not part of the query
will be preserved.
Delete all archives: completely deletes the population archives.
The following window will appear. Select the file date you wish
to restore and click on the Restore button. Pay careful attention:
overwritten data can not be restored.
Figure 23
Its main features are:
Figure 24
To run a query it is possible to specify various query criteria (Fig. 24) such as:
♦ Tests date range;
♦ Analysis code range;
♦ Name;
♦ Surname;
♦ Arrangement by code, surname, test date.
Select all is displayed by default in the fields. In this case, by pressing the Search button
all the data present in the archive will be displayed.
Patients will be ordered by Test Date as long as the operator does not want to order by
Code or Surname.
Choose code
It is possible to enter the information regarding the search range for desired analyses codes
by clicking on the icon (hand) next to "Choose Codes". The search is case sensitive,
meaning that the system distinguishes the capital letters (Upper case letters) from the small
letters (lower case letters).
Clicking on the button "Accept" will save the values entered in the editing fields "Insert Initial
Code" and "Insert Final Code". Pressing of "Cancel" will cancel the operation of the codes
selection.
Choose Name/Surname
Click on the "hand" icon corresponding to "Choose Name" or "Choose Surname" to open
the "Name Selection" window for searching by name or surname. Write name or surname in
the dedicated field and click "Accept" to save the search or click "Cancel" to abort the
operation. The search is case sensitive.
Once the search criteria have been fixed, click on Search button. The patients’ data page
will be displayed as in fig. 24.
Figure 25
View Analyses: this can also be accessed with a double click and is used to display the
information related to the selected patient (Fig. 26)
Info Record: displays the position of the selected record inside the executed query.
Quick Print: immediately prints the report for the selected patient.
View Analyses
Figure 26
With the keys Previous and Next it is possible to scroll the entire patients list.
Send to RS232: sends the results to the Host Computer (when enabled)
Print Preview: opens the print preview of the patient’s report.
In addition to the list of "Analysis" of selected code, the following informations are displayed:
name, surname, test date, group, measurement unit, flags (an asterix identifies tests with
flags; see flag page below), Min - Max range, and notes.
Figure 27
N.B.: the possibility of accessing the Patients’ Archive module and modifying the
analysis values is controlled by password and thus only accessible to authorized
personnel.
See also Chapter E, Paragraph 1.7 Access Password.
Figure 28
Section I Chapter F Q.C. - Population - Patient's Archive Page 26 of 29
3.3. PRINTING REPORTS
The Print All button in figure 24 is used for quick access to a print window with some
options.
Figure 29
In this kind of printout, all patient data are shown, followed by the analyses list with
analytical method, result (with flags) and normal range.
Figure 30
There is another type of printing by test option in the main window of the Patient Archive
(Fig. 24):
Test Report: from here it is possible to select one of the available tests and to print the
corresponding results (Fig. 31 and 32)
Figure 31
All results matching with the search criteria are displayed.
Figure 32
FILE
Load Date and Code: used to load the date for the test
execution dates and patients codes so that they are
available in the query criteria "scroll-box" (par. 3.1.).
Export Data: has the same function as in the Population
archive: see par 2.4 OTHER MENU FUNCTIONS
Exit: is used to close the Patients Archive program.
UTILITY
SetUp: opens the printer setup.
Backup: creates a backup copy of the selected search,
without deleting files from the HD. To create the backup it is
necessary to first perform a search, then select a location
for the backup files.
View External Archive: click on this button, select the
location where the backup files are and then press the
search button to view data.
View Internal Archive: press this button to go back to the
internal archive after having viewed an external backup file.
Format Floppy: it is used to format a floppy disk.
Report with grayed lines: used to select whether to print
the reports in "easy reading" format. Easy reading printing
contains light gray lines alternated with lines the color of the
paper.
DELETE
Delete Records Selected: Allows deletion of only the
randomly selected records.
Delete All Search: it deletes the whole performed search.
Delete All Archive: it deletes the whole archive.
SEND TO RS232
Send Records Selected: sends randomly selected records
to the host computer.
Send All Search: sends the whole performed search to the
host computer.
CHAPTER G
1. DISPLAYING AND PRINTING RESULTS Page: 2
1.1. Results per Patient Page: 3
1.2. Results per Test Page 8
1.3. Displaying Real-Time data Page: 9
1.4. Reaction graphs Page: 11
1.5. Flags list Page: 13
1.6. Sorting results in RT Page: 14
NOTE:
The representation of the test results can be accessed through the specific icons (Fig. 1) for
the two available options: “View results for sample” (results will be displayed for patient)
and “View results in real time” (results will be displayed as the single tests are read).
Figure. 1
By clicking on the icon for View results for sample the operator has the possibility of
viewing the results by sample or by test (Fig. 1).
In the first case the patient data are displayed together with all the analyses run on that
sample. In the second case the results of performed tests are displayed, grouped by
analysis.
Moreover it is possible to view the results for the calibrations or the controls in the
dedicated RT pages.
Figure. 2
Figure 3
It provides access to a page where the flags are listed, with a short explanation of the
meaning of each one (Fig. 4).
Figure 4
PRINT: Print command. It allows two options: Normal print-out (will print the pages as they
are displayed i.e. samples will be printed sequentially) or Printout for sample (will print one
single patient for each page). However, this is not a print-out in report format.
Figure 5
A print preview will be displayed (Fig. 5) where it is possible to select which and how many
pages to print.
Figure 6
In the correction With standard the analyzer runs the recalculation starting from the
absorbance memorized for the test, thus the various analytical parameters and the last
valid calibration are taken into consideration. In this case, if the instrumental factor and shift
have been set in the analytical parameters, they will be used in calculating the new value.
N.B.: If a recalculation result returns a value of 1,000,000 or higher, <NC>, not calculable
will be shown instead of the result. If the returned result is negative, the M flag will be
assigned: error in the parameters (instrumental factor and shift).
NB: In the correction With standard, I.S.E. and Relation Tests results will not be
recalculated.
The E flag (recalculated value) will be assigned to all tests that undergo recalculation.
Use of the correction functions is only for operators authorized with a specific password
(see chap. E, par. 1.7 Access Password).
ARCHIVE DATA saves all the data present on the page on the hard disk. After archiving,
the data will be available, based on type, in the three external programs: Quality Control,
Population and Patient archive. Archive data also includes the deletion of the data from the
visualization pages (per patients and in real time) as well as reaction graphs. Therefore, it is
a good idea to print any pertinent graphs before archiving data.
DELETE RESULTS deletes all the data from the visualization pages (per patients and in
real time) as well as the page of reaction graphs. The data cannot be recovered.
EXIT: closes the page and returns to the main program, without modifying the data.
Section I Chapter G Displaying and Printing Results Page 7 of 15
1.2. RESULTS PER TEST
Figure 7
After the end of programmed task, the results can be viewed per Test. The test Results
display page is shown in Figure 7.
The following information is displayed for each single test:
a) Code and test name The displayed code is the same read on the list of tests, while
the full name between parenthesis is the one assigned by the
operator in the analytical parameters (chap. C, par. 1.3.3.).
b) Sample Position (#XX) Progressive number as programmed in the Setup dedicated
page for Routine and STAT.
Progressive number as programmed in the Setup dedicated
page for STD and CTRL.
c) Sample Code For Patients (Routine and STAT) it is assigned at check-in.
For STD and Batch it is automatically assigned.
e) Results The results of test attributed to patients are represented with:
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets – see also par. 1.5)
PRINT: used to print the contents of the window. This is not a print-out in “report” format. A
print preview will be displayed (Fig. 6) where it is possible to select which and how many
pages to print.
EXIT: closes the page and returns to the main program, without modifying the data.
A window is also available on this page (Info flag button – see par. 1.1.) with information
relative to the flags associated to the results.
Figure 8
This page can be accessed through the specific icon (fig. 1). The data shown (Figure 8)
refer to the results obtained by the analyzer in real time, i.e. as the tests are completed. For
this reason the results of tests with a shorter incubation and reading time may appear first
even if they belong to later patients. The results are not sorted in any way, not per patient,
not for type of test. When no data is present this page is empty.
The data display is synthetic.
c) Date and time The date and time the test was run is between parenthesis.
d) Results The results of test attributed to patients are represented with:
Graphs are divided into two parts by two dashed orthogonal axes. On the left part there is
the incubation time graph, while on the right there is the reading time graph (Fig. 9).
On the right of the window, there are two frames containing the information concerning the
absorbance determined during the two phases (incubation and reading times), Each
division in the Time axis is approx 10secs.
Figure 9
N.B.: The absorbance values read per single point in each phase
are shown at the bottom, under the graph. This data can be exported into a file by pressing
the Export Values button.
Note:
In report printing from patients’ archive, all flags are replaced by the generic symbol
(asterisk).
In the patients archive active flags will be highlighted in red and will have the check in the
corresponding box.
Figure 10
It is necessary first to select the desired options in the Setup and save. In the real time
results page then, select the Sort button to arrange the results on the base of the selection
performed in the Setup. The same arrangement will be performed both for the RT results
and for the calibrations & controls dedicated pages.
Depending on the selection, the results in the real time page will be sorted as follows.
CHAPTER H
1. ANALYZER TECHNICAL FUNCTIONS Page: 2
1.1. Service Functions Page: 2
1.1.1. Analyzer Utilities Page: 2
1.1.2. Mechanical Calibrations Page: 4
1.2. Diagnostic Functions Page: 6
2. ANALYZER SETUP Page: 10
NOTE:
The commands are available in the form of buttons. To access a function just push a
button.
The Exit button on both pages closes the window and saves any settings.
The Analyzer Utilities include items (FCC Calculation, Lamp Setup, Temperature Test and
Empty Fluidics) normally dedicated to technical assistance personnel. These functions
should not be used unless they have been suggested by qualified personnel. Just like for
the other parts of the program or analyzer, these functions must be used according to the
intended use established by the manufacturer, failure to do so will result in warranty
invalidation.
Figure 1
To activate any of the following commands click on the corresponding button (Figure 1):
Wash with water: washes, with the washing solution (bidistilled water and surface active
agent) the cuvettes and leaves them filled with water. This function is recommended when
a work session has ended and the analyzer is not going to be used again immediately.
However, after 20 minutes of inactivity, the analyzer goes into standby and automatically
washes the cuvettes.
NOTE: if one of the analyzer functions is active, remember not to make modifications in the
Setup program. This will cause a reset of the analyzer thus terminating the activated
function.
Figure 2
The Calibrations menu is subdivided into three columns: Clinical Chemistry Arm, I.S.E.
Arm and Tray as shown in Figure 2.
NOTE: bear in mind that only BT3000 Plus and BT3500 systems have two diluters,
two sampling arms and the I.S.E. Module.
1st reagent: the sampling arm moves to the appropriate hole on the instrument’s top for
accessing 1 st reagent. Before starting the calibration a big bottle matched with a small one
must be inserted in position n° 4. Center the sampling needle on the neck of the bottle.
2nd reagent: The sampling arm moves to the position for the second reagent corresponding
to the appropriate hole for accessing small reagent bottle on the instrument’s top. It is
recommended to calibrate the reagent tray prior to calibrating the sampling arm.
Cuvettes position: The sampling arm moves over cuvettes tray. The sampling needle
must be centered on the cuvette.
ISE ARM
The first five items and the Cuvettes position (I.S.E.) are the same as the corresponding
button of the Clinical Chemistry Arm, see them for more information.
Arm on diluent: centers the I.S.E. arm above the tube containing the physiological solution
for diluting the samples.
Arm on funnel: the I.S.E. arm moves above the I.S.E. mixing funnel. Center the sampling
needle at the hole at the bottom of the funnel. It is very important that the needle is
centered in this position to prevent it from touching the funnel walls during mixing.
For more info, see chapter L, par. 1.4.
Figure 3
Show F.C.C.: It shows the optical correction factor calculated for all the reading cuvettes.
For each cuvette, the mABS and the F.C.C. values (Figure 4) are reported. It also indicates
the cuvettes with correction factor exceeding the preset limits (± 3%). It is possible to print
this page.
Figure 4
Figure 5
Show Diagnostic: it shows the status of the various parts of the system that should be
replaced regularly. This page shows the consumable parts, life cycles, remaining cycles
and the possible replacement date (Figure 6). When at the analyzer start up, the message
There are the following obligations in diagnostic, appears, it means that the indicated
item has to be replaced or an action has to be undertaken. In the Show Diagnostic page
there will be one or more red lines corresponding to the parts needing replacement (refer to
Chapter N). Once the required maintenance has been performed, reset the internal
counters of the analyzer, by clicking on the single voice described in the table on the right
side.
Based on how the analyzer is used, the cycles may come to an end before the dates or vice
versa. However, the maintenance requested by the analyzer should be carried out, even if
the actual workload has been light. This guarantees perfect operation of the analyzer. If the
analyzer has not been used for some time, it is advisable to replace the tube kits and
possibly the seals, since they can deteriorate even if not used.
Figure 6
ATTENTION: the maintenance page shown in figure 6 is only an example. Check the
consumable parts mentioned in the analyzer program, the cycles and replacement
dates on the analyzer. Bear in mind that the replacement dates indicated on the
maintenance page are a guideline as they are calculated on an average work day that
may not reflect the needs of each lab.
It is not advisable to use the commands in the Diagnostic program without the assistance
of qualified personnel.
LANGUAGE: on this page (Figure 7) it is possible to select the language (for example
English or Italian) from those available).
Figure 7
If there are no languages on the list they need to be installed. To view all the available
languages, insert the installation disk of the operating program in the CD reader, then press
the Browse the Folder button and browse the disk contents until finding the Language
folder and click on OK (fig. 7a).
Figure 7a
Section I Chapter H Analyzer Technical Functions/Setup Page 10 of 17
SYSTEM: In this page it is possible to modify the following options (Figure 8):
Figure 8
Icons: It enables or disables the displaying of the icons on top of the screen.
Navigation Bar: It enables or disables the displaying of the navigation bar on the left side
of the screen.
Voice: it enables or disables vocal function (vocal messages). By clicking on the icon a
mask appears for selecting and controlling the audio (reproduction speed and volume).
Use European Menu: If disabled, it changes the menu bar as well as the operating
functions from European mode to the ones exclusively dedicated to USA mode.
NOTE: The USA operating modes are not outlined in the present manual.
Print-out real time results with color: When enabled, the real time print-out will be in
colors, otherwise it will be in black and white. Bear in mind that in this way, the identification
at glance of results associated to flags in printouts is lost, as they are normally printed in
red.
Print-out real time results with final report: When enabled, it provides test results per
patient in real time print-out in report format. However, remember that if it is necessary to
execute a re-run, a new print-out would be obtained. This option may be costly in terms of
paper and may cause confusion as there may be several reports printed for the same
sample.
Archive the results with <NC> instead of the value: used to archive all the results,
including those marked as not calculable in the Patient Archive. If this is not enabled, the
results marked with <NC> will not be archived and they will be left on the work list to allow
for re-running them (see Ch. G, par. 1. and Ch. F, par. 3.2.)
Add to extra patient list: during the patient programming phase in Routine, it is possible to
have the analyzer memorize the patients directly on the extra patients list, instead of the
normal work list (see Ch. E, par. 1.5. Work lists). This option is divided into: If not empty
and In any case. In the first case, the patients are saved in the additional list only if it
contains at least one other patient. In any case: the patients are saved directly on the extra
patients list.
N.B.: The patients are transferred to the extra patients list only if the acquisition is via the
New Entry button, and not by clicking directly on a free position on the sample tray (see
Ch. E, par. 1.4.).
This option may be useful in cases where all patients are being programmed, before
actually receiving the samples. As the samples are received the patients are moved from
the extra patients list to the routine list and the work is started.
Figure 9
Figure 10
Figure 11
Setup Bar-code on Samples: This function customizes the contents of the patient code
reported on the bar-coded label.
Dimension Sample Code: This field is used to define the number of characters dedicated
to the patient code. If set to zero, the code length is variable (codes with a number of
characters between 1 and 13 are accepted automatically). If as an example 10 is entered,
then the patient code must have ten characters.
Use a digit for Serum/Urine: If enabled it is possible to use one character to automatically
identify the type of sample (Serum/Urine) undergoing test.
Use one or two digits for profile number: When enabled it is possible to use one or two
characters to identify automatically the profile number assigned during profiles
programming (refer to Chapter C, paragraph 1.6., Creating Profiles).
I.S.E. MODULE: Only available in BT3000 Plus and BT3500. Activates the ISE module
(Figure 13). Check Present to activate or Not Present to deactivate. When the ISE module
is disabled, all relevant menu options will be disabled too or not visible at all.
Figure 13
Figure 14
• Room Temperature
• 30°C
• 32°C
• 37°C
By selecting Room temperature bear in mind that when this is very high the temperature of
the solution in the cuvettes will be high as well. The same thing is true even if the selected
temperature is 37°C, but the room temperature is 40°C, for example. The heating elements
of the cuvette tray are able to heat but not cool if the room temperature is higher than the
programmed temperature.
Enable Reagent Refrigerator: If not selected, it excludes the reagent refrigeration.
Clot detection sensor: Only available in BT3500. The clot detection sensor is used to
verify whether there are total or partial occlusions in the sampling needle, due to proteins or
else. It can be enabled or disabled. There are two thresholds, one high and one low, which
values are set by default for the normal working conditions encountered in labs. It is
possible to modify these values in case the used samples show, for instance, a higher
density and therefore the system gives continuous errors.
If a clot is detected and the sampling arm is obstructed, the sampling for that patient is
aborted, the sample will be flagged with the Z flag: Clot detection <ERROR>. If there is a
possible obstruction of the sampling arm, the analyzer will go ahead sampling, but the
results for that will be flagged with the z flag: Clot detection <Warning>
The clot sensor also detects malfunctioning of the hydraulic circuit, including detached
tubes that cause a sudden drop in the hydraulic circuit pressure. In case this happens, the
analyzer will immediately stop working and will display a proper warning message (Error on
Arm hydraulic circuit...! )
Once an air bubble has entered into the hydraulic circuit, there is no way to fill the hydraulic
circuit again without having the error message. It will be necessary to disable the clot
sensor and perform some dilutor prime or to turn the analyzer off and on again.
Figure 15
Customizes samples’ tray (Figure 15). Here it is possible to change the number of positions
dedicated to the samples of Routine, STAT, Standards and Controls.
Routine and STAT positions are included in the two outermost rings with progressive
numeration from 1 to 52. Standard and Controls positions are in the innermost rings with
progressive numeration from 1 to 26. It is not possible to exclude one typology to
advantage of the other one. The minimum number of assignable positions is 1 for the
Routine, STAT and Standards; and 3 for the Controls.
Click up/down arrows to increase/decrease the number of dedicated positions, or write the
desired number into the textbox. The analyzer will automatically upgrade the positions for
the second item of the pair every time the first one is changed.
Only for BT1500 & BT35000: Routine and STAT samples share the dedicated positions
from number 1 to 62. The two outermost rings with progressive numeration from 1 to 52
allow placing of primary tubes or cups. The positions from 53 to 61 will allow only cups.
Standard and Controls shared positions are in the innermost rings with progressive
numeration from 1 to 16 and allow placing of cups only.
Figure 16
ATTENTION: when writing any of the passwords in one of the three appropriate field, it is
necessary to confirm it by pressing Enter. This will also enable the following writing field. If
the procedure is correct, the analyzer will display a message confirming that the password
has been changed.
CHAPTER I
1. BARCODE AND RELATED FUNCTIONS Page: 2
2. USING THE BARCODE Page: 2
2.1. Barcode on Samples Page: 2
2.2. Reagent Barcode Page: 5
EXAMPLE 1
Patient ID# of digits: 10 With one digit for serum or urine: no With two digits for profile: no
1234567890
PRINTED CODE: 1234567890 TOTAL 10 CHARACTERS
EXAMPLE 2
Patient ID# of digits: 10 With one digit for serum or urine: yes With two digits for profile: no
1234567890 1
PRINTED CODE: 12345678901 TOTAL 11 CHARACTERS
EXAMPLE 3
Patient ID# of digits: 10 With one digit for serum or urine: yes With two digits for profile: yes
1234567890 1 99
PRINTED CODE: 1234567890199 TOTAL 13 CHARACTERS
If in the Setup the number of digits for the patient ID is set to 15 and the printed code is of
10 characters, the analyzer will consider as ID# the 10 printed numbers.
If in the Setup the number of digits for the patient ID is set to 13 and the printed code is of
10 characters, the analyzer will consider as ID# the 10 printed numbers.
If in the Setup the number of digits for the patient ID is set to 13 (serum/urine digit and
profile number are active) and the printed code is of 13 characters, the analyzer will not
consider the digits for serum/urine and for profile number as it is expecting the patient ID to
be of 13 digits. The patient ID always has the priority on the following numbers.
EAN13
If the bar-code used is an EAN13, the sample bar-code can be programmed as follows.
NOTE: with the EAN13 there are some limitations: the first number must not be 0; the
actual number of digits is 12 as the last digit is the checksum X (automatically created).
EXAMPLE 1
Patient ID# of digits: 12 With one digit for serum or urine: no With two digits for profile: no
123456789012
PRINTED CODE: 123456789012X TOTAL 13 CHARACTERS
EXAMPLE 2
Patient ID# of digits: 11 With one digit for serum or urine: yes With two digits for profile: no
12345678901 0
PRINTED CODE: 12345678901X TOTAL 13 CHARACTERS
EXAMPLE 3
Patient ID# of digits: 9 With one digit for serum or urine: yes With two digits for profile: yes
123456789 1 99
PRINTED CODE: 123456789199X TOTAL 13 CHARACTERS
Other codes can be programmed upon request. They are available in blocks of six and are
uploaded by floppy disk.
Some of these codes available upon request include:
2/5 INTERLEAVED, CODE 39, CODE 39 FULL ASCII, CODABAR, CODE 128, EAN 128,
CODE 93, PLESSEY, PHARMACODE, ALL EAN/UPC, EAN 13, EAN 8, UPC A, UPC E,
EAN 13 ADDON 2, EAN 8 ADDON 2, UPC A ADDON 2, UPC E ADDON 2, EAN 13
ADDON 5, EAN 8 ADDON 5, UPC A ADDON 5, UPC E ADDON 5, EAN/UPC w/o ADDON,
EAN/UPC ADDON 2, EAN/UPC ADDON 5, EAN/UPC ADDON N
“Check volumes”
This command allows measurement of the volume of the reagent bottles (refer to Chapter
E, paragraph 1.2. “Reagents: insertion and removal”). With reagent barcode enabled, it
is also possible to check the actual position of all the bottles in tray.
At the end of the reagent scanning, the analyzer sorts codes disposition and provides a list
of all the errors found during reading phase. In case of detected anomalies, the procedure
can be repeated once the problems have been solved. Every time a new reagent bottle is
inserted, the analyzer will read the inserted codes.
When removing a reagent with the "Remove" function, the analyzer will perform a scan of
the position to verify that the reagent has been removed. When closing the View volumes
status window, the analyzer will perform a second verification scanning and then will move
the removed test code from the on-line tray to the global list (see also Cap. E, page 3).
CHAPTER K
1. VACUUM PUMP SYSTEM INSTALLATION/OPERATION Page: 2
1.1. Functional characteristics Page: 2
1.2. System control functions Page: 3
1.3. Waste container (external) Page: 3
1.4. Installation & operation Page: 4
1.5. Maintenance and care Page: 4
1.6. Trouble-shooting Page: 4
1.7. Spare parts for maintenance Page: 5
NOTE:
Normal Pressure
WARNING
Low Pressure 1) Read vacuum pump system
instruction and warning
notices carefully
Low-Pressure Alarm
2) Disposable gloves must be worn when
servicing the vacuum pump system
where hands may contact potentially
contaminated waste materials
biotecnica instruments
Figure 1
Vacuum Pump System P/N 06-05161-01
This silent and compact vacuum pump system has been specifically designed for use with
this analyzers. It provides for an automatic and safe collection of waste liquids from
analyzer’s reaction cuvettes and sampling needle washing into the external waste disposal
container in lab environment. The system consists of a metallic cabinet containing two
membrane pumps controlled by a microprocessor, electronics, and the electrical and fluidic
connections to the analyzer. The microprocessor manages three main functions: pressure
measurement, waste container full check, and pump shutdown. The waste discharge has
the following pathway (course):
A) The liquids aspirated by the pumps from the needle washing funnels (bowls) and the
cuvettes washing through the two tubes (Blue and Black tubes) respectively are
transferred to an internal waste chamber (made of transparent Pyrex). From here,
the waste fluid is ejected to the external waste container through the waste probe
equipped with liquid level sensor.
B) Whenever the external waste container is full, the waste liquid level sensor activates
an audio/visual alarm that alerts the operator and instantly shuts down the pumps.
Simultaneous lighting of Green, Yellow, and Red LEDs: Indicate high vacuum level
(higher than –150 millibar).
The simultaneous lighting of Green, Yellow, and Red LEDs indicate excessive vacuum
level probably caused by an occluded waste probe tube (from the vacuum pump system to
the external waste container). If this condition occurs sporadically during washing then it
must be considered normal.
All LEDs turned off condition is reached when the standby time (2 minutes) terminates
without resetting the system (pumps disabled). In this case, the green LED of the Restart
button flashes in quick successions.
NOTE:
The liquid level sensor is magnetically actuated reed switch make and break type.
1.6. TROUBLE-SHOOTING
TROUBLE-SHOOTING GUIDE
SYMPTOMS CORRECTIVE ACTIONS
a) No power to the system. Power cord disconnected.
The vacuum pump is silent and Restart Connect the power cord.
green LED not lit. b) Blown fuse/s. Replace with appropriate fuses as
marked.
Indicates vacuum level variation due to leakage in the
hydraulic circuit connection/s. Ensure that the waste tubes
Audible alarm of intermittent frequency, (blue and black tubes connecting vacuum pump to the
some flashing LEDs and the instrument analyzer) are firmly connected.
in standby mode. During the analyzer operation, this phenomenon may be
considered normal, as there may be sudden variations in
the vacuum level during emptying of the reading cuvettes.
Aspiration Pump
External Waste
Container
Fluidic Pathway
Figure 2
Drain Tube
Electric Cable
Level Sensor
Red LED
CHAPTER L
1. ISE MODULE Page: 2
1.1. Introduction Page: 2
1.1.1. Contents of the wooden crates: I.S.E. Page: 3
1.1.2. Applied Mathematical Functions Page: 3
1.2. Performance And Limits Page: 4
1.3. I.S.E. Wash and system shut down Page: 5
1.4. Mechanical Calibrations: I.S.E. Arm Page: 5
2. Operating the I.S.E. Module Page: 6
2.1. Parameters Page: 6
2.2. Programming Standards and Controls Page: 8
2.3. Replacing and Installing Electrodes Page: 11
2.4. Preliminary steps before starting the system Page: 12
2.5. Calibration procedure Page: 13
2.6. Measuring unknown samples Page: 15
3. Precautions, maintenance and Troubleshooting Page: 16
3.1 Precautions for ISE Module usage Page: 16
3.2. Suggestions for performance maintenance Page: 17
3.2.1. I.S.E. Maintenance Page: 18
3.3. Troubleshooting Page: 20
4. Returning The Analyzer To The Tech. Assistance Service Page: 24
5. I.S.E. Module Consumables Page: 26
NOTE:
1.1. INTRODUCTION
In addition to the Clinical Chemistry and Immune-chemistry tests, the BT analyzers allow tests for
the Na+, K+, Cl- and CO2 ions with ion selective electrodes (ISE module).
The device consists of a reading module with a partially dedicated sampling arm and therefore can
be considered as a stand-alone module of the instrument.
The system is called Ion Selective as the electrodes used respond to their respective ions in
accordance with the Nernst equation:
Ground
electrode
WORKING SOLUTIONS
BT3000 Plus
Concentrated Buffer Solution: 45 µl + 350 µl (H2O) approx
Concentrated Reference Solution: 45 µl + 350 µl (H2O) approx
Sample Volume: 30 µl
Concentrated Buffer 10 ml: 200 tests approx
Concentrated Reference Solution 10 ml: 200 tests approx
BT3500
Concentrated Buffer Solution: 34 µl + 280 µl (H2O) approx
Concentrated Reference Solution: 34 µl + 280 µl (H2O) approx
Sample Volume: 23 µl
Concentrated Buffer 10 ml: 300 tests approx
Concentrated Reference Solution 10 ml: 300 tests approx
RUNNING TIMES FOR UTILITY
TIME WASHING SOL. (approx)
ISE wash 12' 20 ml
Consumption per ISE test 10 ml
NOTE: stated times and liquid consumptions should be considered
only as indicative as they may vary in different conditions.
Wash I.S.E. Module: It is used for a complete extra wash with appropriate solutions (ISE
Cleaning Solution and Enzymatic Solution) of the fluidic circuit of the ISE module. This
washing procedure must be run daily, at the end of the day. This is to guarantee correct
maintenance of the electrodes. Like wash cuvettes this procedure can be run when the
analyzer is shut off (using the guided shut down procedure) or at the end of the day if the
analyzer is not shut off.
2.1. PARAMETERS
Go to the Global list or the Current Tray list select ISE, and then click Parameters to
display the screen showing analytical parameters: General Parameters, Serum’s
Parameters, and Urine’s Parameters.
N.B.: the I.S.E. parameters have been optimized for this analyzer. The parameter
fields marked with an asterisk should not be modified. Biotecnica Instruments S.p.A.
shall not be held liable for unreliable results if the I.S.E. parameters are changed.
The General Parameters is displayed first (Figure 1), to access the other parameters click
on the corresponding tags.
GENERAL PARAMETERS: In this page it is possible to program the general parameters for the
ISE. The I.S.E. module test parameters are preset and should not be modified because the I.S.E.
module has been designed to operate best with the parameters supplied by Biotecnica. The
description and use of the parameters is very similar for what is described for clinical chemical
parameters, see that section for more information.
Use the command Save for memorizing data, Cancel for leaving the program without
saving changes, and Print for hard copy printout.
The displayed page is divided into two parts, one for the Known controls and the other for
the Unknown controls (Figure 5). The opening page is default set to Level (1) controls. To
set parameters for Level 2 and 3, click corresponding tabs.
KNOWN CONTROLS
Sample position: Enter the sample’s physical position on the plate. The reserved sample
positions are located in the inner circles of the sample plate and are dedicated to calibrators
and controls. The numerical positions on the sample plate correspond to those established
in the Setup Analyzer (refer to Chapter H, paragraph 2. Setup Analyzer).
Low value: Enter the lower value for the control’s range.
Theoretical Value: Enter the theoretical value for the control.
High value: Enter the higher value for the control’s range.
Timed re-run: This parameter
allows programming of automatic
execution of controls. It is
possible to insert automatic
execution time for each single
control. Check Timed re-run box
and then Click Timed re-run (just
above the View used positions) to
Figure 6 display Insert re-run timing screen
(Figure 6).
Here one can enter interval of hours or days (refer to Chapter C, paragraph 1.4.) for
automatic controls run.
WARNING
Do not touch with bare hands the small metallic tubes of the electrodes, the contacts
of electrodes, or the sensor electronics, in order to avoid electrostatic discharges
that may cause permanent damage or system malfunction.
PERISTALTIC PUMP
DILUTOR
DILUTOR’S PINCH
VALVE
PUMP CARTRIDGE
SR 10/30
Figure 7
1. Before installing or replacing electrodes, remove the ISE module as shown in Figure 7
and unscrew the thumbscrews securing the metallic shield.
2. Disconnect the tubes 2, 3, 4, 5 and 6 (Figure 8) from the electrodes. Remove the
housing containing measurement electrodes (K, Na, Cl, By-pass or CO2) by gently
moving leftwards (Figure 8). Remove the housing containing Reference and Ground
electrodes by carefully moving it rightwards. Keep these housings in vertical position
when electrodes are present.
3. Carefully remove the electrodes from their respective housings by gently pressing on
the backside. Always maintain the electrodes stack in vertical position.
4. It is recommended to immediately disconnect the first electrode (K) from the next one.
5. Replace the defective electrodes with new ones.
6. Reassemble the electrodes stack and place it into its housing.
7. Position the housing with the measurement electrodes on the ISE panel, and gently
press fit to the right into the appropriate connecting pins of the detection electronics.
8. Carefully fit the housing with Ref & Ground electrodes by gently pushing to the left into
the pins of the detection electronics.
9. Reconnect tubes 2, 3, 4, 5 and 6.
10. Secure the metallic shield using the thumbscrews.
11. Insert ISE module into its appropriate slot.
4
5
Figure 8
2.4. PRELIMINARY STEPS BEFORE STARTING THE SYSTEM
This procedure is necessary when installing the system or after replacing the electrodes.
For normal operating functions, observe the following procedure:
a) Place the working solutions in their respective lodgings (Figure 9).
b) Make sure that the contents of the working solutions are sufficient for the necessary
workload.
Caution
This verification of volumes (for necessary workload) is highly recommended. Whenever
baseline or buffer solutions are changed, a new calibration of the system must be
performed.
c) Run Prime I.S.E. (refer to Chapter H, paragraph 1.1.1.) and repeat it for at least three
times.
Working
Solutions
Figure 9
Section I Chapter L I.S.E. Module Page 12 of 26
NOTES: if the device has just been installed, the electrodes have been replaced or if the
I.S.E. module has not been used for some time, various system primes should be run. Wait
around 30 minutes before using the I.S.E. module to let the electrodes by conditioned by
prior passage of the reference solution.
d) Verify that programmed values for the standards (high level/low level) correspond to the
used lot. Programming is performed as shown in Figure 4, where the values for two
standards must be entered for the calculation of slope during the calibration.
e) To reduce the risk of contamination of baseline and buffer solutions through ambient air,
it is suggested to remove and close the two bottles at the end of daily working sessions.
Remember to open and replace these bottles at the beginning of every new working
session.
The ISE module should be considered by the user as an ordinary test for Clinical Chemistry
requiring a programming of its own for standards and controls. Calibration should be
performed every four hours and it is essential for precise and accurate results. In addition, it
is recommended to execute repeated calibrations until a stable slope value is obtained.
NOTE:
In addition to the acquired slopes values, it is important to observe also the potential of the
standards mV STD Low and mV STD High in the calibration printout.
In the optimal conditions, these values can be reproduced quite easily with slight variations
around nominal value. The potential of the standards in association with the obtained slope
values, are useful for evaluation of a correct calibration. When electrodes are not efficient,
for example, when poor or no maintenance has been performed, or in case of
contamination or degradation of the working solutions (Buffer, Baseline, or STD), the
potential values vary considerably. This results in erroneous slopes indicating that the
operating conditions are not optimal. However, in some cases, the potentials have incorrect
values, but the slopes are apparently acceptable. Be cautious with this situation as the
precision and accuracy of tests results will be affected by an incorrect calibration.
IMPORTANT NOTICE
a) After an incorrect calibration or in case of a calibration beyond the preset limits, the
analyzer automatically performs a new calibration with up to 3 calibrations maximum.
b) Once the calibration standards are poured into the sampling cups, they are stable for no
longer than 15 minutes. If calibrations, for any reason, last longer than this time, it is
necessary to replace standards with fresh ones and repeat the calibration. The bottles
containing buffer and reference solutions must be placed on the analyzer (open bottles -
at room temperature) at least 30 minutes before operating phases begin and to allow for
equilibrium with ambient temperature and with the carbon dioxide (CO2) level in the air. If
the thermal equilibrium is not reached, then the phenomena of drift effects and erroneous
results can occur, while a lack of equilibrium with CO2 may provide higher results for the
latter test.
NOTE:
If slopes and potentials are constantly out-of-range, this indicates that the electrodes are
exhausted, or there is an aspiration error of the reference (baseline) solution in the
reference electrode, or the working solutions (buffer, baseline, STD) are contaminated or
degraded. In case of contamination or degradation, replace in sequence the buffer solution,
then the reference solution and at last the standard. Whenever a product is replaced,
repeat the calibration procedure. In the other cases such as exhausted electrodes or a
baseline aspiration error in the reference electrode, refer to the Troubleshooting guide.
Note: the Kit tubes and peristaltic pump items are contained into the BT3000 Plus Six
month maintenance kit (code 11-05337-01) and in the BT35000 Six month maintenance kit
(code 11-05669-01). The other items are contained in the following dedicated kits.
BT3000 PLUS: QUARTERLY MAINTENANCE KIT (CODE 11-05338-01)
ITEM QTY DESCRIPTION
1 1 REF - K Tube Manifold
5 1 Interconnection Tube for GND/Bypass OR CO2 Electrode
6 1 ISE Pump Tube
- To access the ISE Module, remove the plastic lodging for the reagents. Slide up the
ISE electrodes panel to have an easy access to disconnect the waste tube
connecting peristaltic pump to the ISE Module.
- Replace the Y-shaped tubing set (ref. 1 figure 7) by first inserting the single tube end
into the bubble sensor, and then connect it to the funnel located above. Insert the
remaining two tube attachments into the appropriate slots (K tube in the upper slot
and the REF tube in the lower slot) of the pinch valve and then correctly connect
their ends to the REF and K electrodes as shown in the figure. Verify correct tubing
placement in the pinch valves.
- Replace the I.S.E.-peristaltic pump tube (ref. 6 figure 7) by connecting one end to the
ground electrode, then around the pump head, and the other end to the waste liquid
connector as illustrated. Then clip the tube holders to the tightener support.
- Connect interconnection tube (ref. 5 figure 7) to the CO2 electrode (or By-pass) and
the ground electrode.
- Replace peristaltic pump cartridge (ref. 7 figure 7): remove both ends of the
peristaltic pump tubing from the diluter manifold. Squeeze the locking catches and
remove the defective cartridge. Place the new cartridge on the drive shaft and gently
press to snap-fit. Carefully attach the pump tubing to both fittings in the diluter
manifold.
- Replace tube (ref. 8 figure 7) connecting the peristaltic pump through pinch-valve to
the dilutor.
- Carefully lower the ISE electrodes panel back into place ensuring that the tube (ref. 6
figure 7) is free and not pinched or crushed by the panel.
2
1
8 7
4
5
Figure 10
I.S.E. Electrodes
The I.S.E. electrode for sodium (Na) and I.S.E. reference electrode (Ref) need to be
replaced on an annual basis. The I.S.E. electrodes for potassium (K), chloride (Cl) and
carbon dioxide (CO2) need to be replaced quarterly. The by-pass electrode, sometimes
present in the place of another electrode not in use, does not require maintenance.
I.S.E. Electrodes
1 Ref. El. Code Description
1 K 662.0712 Potassium electrode
2 Na 662.0711 Sodium electrode
3 Cl 662.0713 Chloride electrode
2 4 CO2 662.0716 Carbon dioxide electrode
4 ByP 662.0709 By-Pass electrode
5 Ref 662.0710 Reference electrode
3
5
Figure 11
a) CALIBRATION ERRORS
The causes may be due to various reasons and can be diagnosed through close
examination of mV values of slopes.
Typical values of calibration potentials in mV:
K std low = -8 mV
std high = +22 mV difference 30 mV (slope 57 mV)
The above-mentioned values are indicative and may deviate due to the wear and tear of the
electrodes.
A positional error or an incorrect concentration of reagents may determine a considerable
variation of potentials and slopes.
The mV values (in brackets) in the calibrations printout can give additional indications,
which are useful for the diagnostics.
For example:
Std low -8mV (-208 -200)
Std high +22mV (-178 -200)
One can observe in the above example the Baseline value (-200), which must be always
included between two Std values. In fact the value -200 is between the two values -208 and
-178.
Generally, this phenomenon occurs during sampling but it may take place afterwards. Observe the
above-mentioned diagnostic procedures.
During a calibration or a run an error message Air bubbles may appear. The error may be
momentary and not appear afterwards. In this case, it means a casual formation of bubbles.
The bubble error in the I.S.E. is managed as follows:
a. If the bubble error occurs during the prime, the analyzer should give the bubble error
warning, all the following I.S.E. samples will have to be flagged with B and will have
<NC> instead of the result.
b. if the bubble error occurs during the sampling, while reading the baseline, the
analyzer should display the bubble error message, should stop sampling and should
give all the following I.S.E. samples results as <NC>, with flag B.
c. In case bubbles are detected while reading a sample, the warning message should
be displayed. The sample will be flagged with B and will have <NC> instead of the
I.S.E. result. The analyzer will go ahead with the following samples.
If the bubble error persists then it may be due to problems of hydraulic nature.
a) ISE funnel takes long time to empty. It may be caused by defective or worn peristaltic
pump for draining or an obstruction in the electrodes stack. Repair or replace.
b) Prime operation failure. The Prime also calibrates the bubble sensor. Check that prime
is performed properly.
c) Collapsed tube in the ISE pinch-valve. The Baseline solution doesn't enter the
Reference electrode and the funnel doesn't empty. The Reference electrode is filled
during the prime. Check and correct.
d)
Results with flag D
During the reading, the flag D on one or more electrodes indicates a drift of potential greater than 2
mV. The phenomenon may be determined by one of the following causes:
• Defective electrode.
• Electrode to be reconditioned.
• Partial occlusion of the electrode.
• Incorrect reagents.
• No washing after a consistent run.
• Correlation with general problems already explained.
NO SPECIAL REAGENTS
The error message NO ISE BUFFER SOLUTION /
NO ISE REFERENCE SOLUTION is displayed when
NO I.S.E. BUFFER the analyzer detects the absence of ISE buffer
SOLUTION solution or reference solution needed for
programmed tests. Immediately after this message
NO I.S.E. REFERENCE the ISE sampling is interrupted. Insert new buffer /
SOLUTION reference and perform a new I.S.E. calibration. It is
possible to repeat interrupted tests using the Re-run
option (Chapter E, paragraph 1.5).
NOTICE
It is often possible to extend the life of a chloride electrode by using the supplied
CHLORIDE ELECTRODE NEEDLE TOOL P/N 03254.
1. Grasp the NEEDLE TOOL as shown. Gently insert the tip of the needle tool into either
end of electrode. Keeping your fingers off the opposite end of electrode, slowly but firmly
push the needle straight through the electrode's inner core until the needle tip appears at
the other end of the electrode (be careful not to bend the needle inside the electrode). Wipe
off any debris on the needle tip and gently pull the needle back out of the electrode. Wipe
off the needle and remove any debris or moisture from the electrode surface. Repeat on the
other side of the electrode and until the needle tool tip is perfectly clean when exiting from
the electrode.
2. Reinstall the electrode into the electrode housing in the correct order.
3. Install the electrode housing into the ISE. Connect tubing and prime the ISE module
completely. If the electrode's performance does not improve, contact your local Technical
Support.
WARNING
NEEDLE TOOL can damage all other electrodes (K, Na, CO2, REF). Do not use!
CHLORIDE ELECTRODE
NEEDLE TOOL
GND
Electrode
REF
Reference
Electrode
REFERENCE
SOLUTION
CONCENTRATED
(DILUTED 1+9)
CLEANING TOOL, P/N 03254
REFER TO INSTRUCTIONS IN
THE FIGURE 13
Na Sodium
Electrode
K Potassium
Electrode
Cl Chloride
Electrode
CO2 Carbon
Dioxide
Electrode
REF
Reference
Electrode
CLEANING PROCEDURE
1. Carefully insert the tip of 5ml - 10 ml syringe filled with appropriate solution onto the top duct of
electrode assembly as shown.
2. Inject solution until all the solution is forced through interconnecting bores of the electrodes and
flows out from the bottom electrode, thus thoroughly removing any contamination.
WARNING
a. PUSH THE PLUNGER ONLY TO EJECT THE SOLUTION. DO NOT PULL THE PLUNGER TO
ASPIRATE THE SOLUTION INSIDE ELECTRODES. THIS WILL CAUSE IRREPARABLE DAMAGE AND
CONTAMINATION TO THE POTASSIUM ELECTRODE WITH Cl OR CO2 PARTICLES.
b. DO NOT USE PLASTIC STRING FOR CLEANING THE REFERENCE OR Na ELECTRODES AS IT MAY
DAMAGE THE ELECTRODES INTERNALLY
Figure 13
Section I Chapter L I.S.E. Module Page 23 of 26
4. RETURNING THE ANALYZER TO THE TECHNICAL ASSISTANCE
SERVICE
FOR MORE INFO REFER TO CHAPTER M
Operating Analyzer
1. Remove all the consumable parts, still present, from the analyzer (sample cups, test
tubes, reagent bottles etc.).
2. Put a suitable decontaminant (e.g. HCl 1N hydrochloric acid diluted at 3%) in a
reagent bottle and place it in position no. 40 for BT3000 Plus & BT3500 (or in
position 24 for BT1000 & BT2000 Plus).
3. Prepare a bottle of enzymatic solution for washing the I.S.E. and place it together
with the other I.S.E. solutions in the specific housing.
4. Start a cuvette (Analyzer Utilities menu – Wash cuvettes) and I.S.E. (Analyzer
Utilities menu – Wash I.S.E.) wash cycle.
5. Wait five minutes after the washes have finished and then remove the
decontaminant bottle from the reagent tray and put the I.S.E. enzymatic solution
back in the refrigerator. Remove all the other bottles of I.S.E. solutions.
6. Run a normal wash cycle with water (Analyzer Utilities – Wash with water).
7. Empty the hydraulic circuit (from the Analyzer Utilities menu - Empty fluidics).
8. Shut down the analyzer.
9. Clean off the entire sample tray with decontaminant and a clean cloth, as well as its
housing and all the accessible surfaces of the analyzer.
For assistance at the Lab: in addition to the above, disconnect the waste tubes from
the instrument and clean an area with decontaminant which is large enough for the
Technician to work.
If the analyzer is going to be returned to the Distributor, make sure all the removal parts of
the system are bagged and separated after decontamination so that they can be disposed
of as special waste.
CHAPTER M
1. WARNINGS AND PRECAUTIONS Page: 2
1.1. Potential risks during operation and maintenance Page: 2
1.2. Warnings and precautions Page: 3
1.3. Waste disposal Page: 6
1.4. Returning the analyzer to the T.A.S. Page: 6
1.4.1. Operating Analyzer Page: 6
1.4.2. Not Operating Analyzer Page: 7
1.5. Analyzer safe disposal Page: 8
1.6. Electric and electronic devices disposal Page: 9
The computer box of BT analyzers is designed for long-term security and reliability
and is virtually maintenance-free as long as the user does not install any third-
party application programs. If these applications are installed, then they may
damage the operating system registry and may also cause disastrous
consequence for the computer's hard-drive. Biotecnica Instruments S.p.A. will not
be responsible for any damage to the analyzer, its software and data in the hard-
disk in case of improper use of the PC box. This includes also: installation of
external programs, not properly secure net connections (intranet and internet) and
the use of disks without the necessary verification for viruses presence. Biotecnica
Instruments S.p.A. will not be responsible for any damage caused by non
authorized third parties who may open and alter the PC box configuration.
USE
Although the BT analyzer system uses high performance components, which provide a
high degree of safety, it is essential that the user takes the usual precautions to
safeguard himself and to ensure a safe working environment.
Biotecnica Instruments S.p.A. only guarantees the workmanship and materials of its
products. It is the duty of the user to take care of safe operation and no amount of
warnings can take place of such care.
As regards the moving parts in the analyzer, these have been appropriately protected to
avoid any potential risks to the user, and for proper instrument operation and safety.
However, it is highly recommended to exercise extreme care during analyzer operation
and especially when working close to the devices.
To avoid accidental contamination, use suitable guards and/or personal protection, such
as overall and gloves. When handling reagents, it is advisable to observe good
laboratory practice (GLP) rules.
Chemicals, serum samples and reagents must be handled with extreme caution. Patient
samples may be biologically hazardous. The reagents or any other substances that may
enter in contact with samples should be treated in the same way as samples themselves.
The materials of human origin, such as control sera, are tested for the detection of
HbsAg, anti-HCV anti-HIV-1 anti-HIV–2 antibodies. Even if the result is negative, as
no known analytical method can exclude any infection’s risk with certainty
therefore these materials must be considered as potentially infective and thus
must be handled with extreme caution. The reagents and any other substance
entering in contact with samples must be treated in the same way. The reagents must be
manipulated (before, during and after the use) by qualified personnel familiar with their
characteristics in order to safeguard the user as well as the quality of the reagent itself.
MAINTENANCE
• It is of extreme importance that the instrument is fully turned off and the power cord
unplugged from the wall outlet to safely perform any maintenance or service
procedure.
• During maintenance procedures (see "Chapter L, “Maintenance“), the safety and
warning precautions must be observed as outlined in the preceding paragraph.
• The exterior of the analyzer casing may be cleaned periodically to remove dust
grease and other contamination. It is not necessary to clean the inside. Use soft cloth
dampened with a mild solution of detergent with water.
• The owner shall be responsible for maintenance of the analyzer. Wear or damage
caused by lack of normal maintenance or by misuse of the analyzer shall not be
considered as defective workmanship and material.
NOTE:
a) The careful observation of the proceeding warnings should result in a long and
satisfactory performance. If the above-mentioned notices are not fully observed, then any
form of warranty is no longer valid and Biotecnica Instruments S.p.A. will not be
responsible for any subsequent damage or loss. (see Section II, 2 “Warranty
Conditions”).
b) The information in this manual is based upon the hardware and software currently in use.
Biotecnica Instruments S.p.A. reserves the right to make software and hardware changes
or improvements for product enhancement without notice and without imposing any
obligation upon itself to install these changes or improvements on its products
previously manufactured.
If the analyzer is going to be returned to the Distributor, make sure all the removal parts of
the system are bagged and separated after decontamination so that they can be disposed
of as special waste.
Editor’s note: The picture is only for the purposes of example: see the printed version in the Italian Official
Gazette no. 175 of 29-7-2005
7. Legislative Decree 151/05 includes a list of fines for illegal disposal of WEEE.
NOTE:
The manufacturer shall not be held liable for any failure to comply with regulations regarded
to delivery of the instrument to third parties. Check the pertinent lists at specialized waster
disposal centers.
CHAPTER N
1. MAINTENANCE AND CARE Page: 2
1.1. Preventive maintenance and Extra Wash Page: 2
1.2. Replacing tubing and accessories Page: 3
1.2.1. Clinical Chemistry Page: 3
1.2.2. Extra wash cuvettes Page: 5
1.2.3. Photometric lamp Page: 5
1.2.4. Dilutors’ piston o-ring Page: 6
1.3. Cleaning the instrument Page: 7
2. MALFUNCTIONS Page: 8
2.1. Troubleshooting Page: 8
2.2. Screen messages Page: 9
2.2.1. Screen messages - Causes and remedies Page: 10
2.2.2. Messages requiring technical assistance Page: 12
2.2.3. Optical system verification messages Page: 14
NOTE:
Exercise extreme care to ensure that the system is regularly provided with proper maintenance
and care to avoid any problems and malfunctions, which can potentially generate erroneous
results. This will give longest life at lowest overall cost.
The maintenance is normally performed at regular intervals or whenever the operating
conditions dictate it. The analyzer stores the number of run tests and a built-in maintenance
software automatically alerts the operator through on-screen messages whenever any part
needs attention or replacement. Failure to follow proper maintenance and replacement
procedures may result in system malfunction.
The software programmed maintenance does not exonerate the user from neglecting any
unexpected problems.
For the reasons just mentioned, we recommend that the operator follows the suggestions below:
The following simple steps serve as practical guidelines in establishing your care and
maintenance program:
1) Replace the worn out component soon after the on-screen message from the maintenance
software has been displayed (Figure 1 “Show Diagnostic”). To access this function refer to
chapter H.
2) Any consumable part showing signs of wear or damage should be immediately replaced,
even if the appropriate on-screen message is not already displayed.
3) Use only original Biotecnica parts. Do not replace defective parts with non-original parts as
this will cause malfunctioning of the analyzer. In case of any doubt, contact the Biotecnica
Instruments S.p.A. or nearest service center.
4) Use only bi-distilled water for the washes performed during working phases.
5) Use only Biotecnica Instruments S.p.A. approved wash solution for the routine washing
procedures and at the end of working session.
6) During routine maintenance, exercise extreme caution to avoid any contamination. When
replacing tubing, needle, or handling waste container etc. accidental contact with potentially
contaminating liquid is possible. For individual safety, use suitable protective garments, such
as overalls and gloves (refer to Chapter K, paragraph 1.1. “Potential risks during use and
maintenance”).
Figure 1
PROGRAMMED MAINTENANCE
Item Replacement
Kit tubes and peristaltic pump Every 150000 cycles or 6 months
Kit tubes I.S.E. module Every 6 months
Photometric lamp Every 1500 hours of use
Dilutor's piston seal Every 300000 cycles or 12 months
Note: the reading cuvettes are also part of the reading station, but they do not need to be replaced
unless it is impossible to wash them correctly or they break. If they need to be replaced contact the
Technical Assistance Service.
The annual maintenance kit corresponds to the “Tube and Peristaltic Pump Kit” on the Diagnostic
page (fig. 1)
4A
1 3 6
Figure 2
BT1000, BT1500 & BT2000 PLUS: ANNUAL MAINTENANCE KIT (CODE 662.2001)
ITEM QTY DESCRIPTION
1 2 Diluter/Valve Tube
2 1 Aspiration Tube for Washing Module
3 1 H2O Tube for Washing Module
4 1 Peristaltic Pump Cartridge
4A 1 Peristaltic Pump Tray
5 1 Tubular Filter for Water Container
6 1 Sampling Needle
Figure 3
Figure 5
Code Description
Dilutor piston o-ring kit BT1000, BT2000 Plus
11-05283-01
(contains what is necessary for one dilutor) BT3000 Plus
330.5741 Ring-flon for diluter piston BT3500 & BT1500
2.1. TROUBLESHOOTING
The risk of encountering system malfunctions is very low if the routine care and
maintenance procedure (outlined in the previous chapter) and the instructions in the
operating manual are strictly observed. Refer to the troubleshooting guide below and the
subsequent text regarding symptoms and corrective actions.
Results are invalid or cannot be reproduced due to air in the sampling system.
Sampling imprecision due to the presence of air in the hydraulic circuit. Probably caused by
the clogged tubular filter in the external water container:
Check, replace Filter if necessary (ref. 5 Fig. 2).
Sampling imprecision due to deteriorated tube in the dilutor valve:
Inspect and replace Tube (ref. 1 Fig. 2).
Sampling imprecision due to reagent or sample residues in the sampling tube or in the
needle:
− Inspect and replace Peristaltic Pump Cartridge (ref. 4 Fig. 2).
− Check and replace the Sampling Needle (ref. 6 Fig. 2).
− Check and replace the Sampling Tube. To be replaced by qualified service technician
only.
Sampling imprecision due to reagent or sample residues on the external surface of the
needle, with consequent contamination during preparation:
Remove Needle and clean externally using gauze soaked with alcohol (ref. 6 Fig. 2).
Check the efficiency of built-in devices for needle cleaning. In case of vacuum pump
malfunction or if there are any obstructions in the cleaning devices, contact immediately
the nearest Biotecnica sales/service office.
NOTE:
Check sampling/washing hydraulic circuit for leaks, which may affect system
performance.
IMPORTANT NOTICE:
The above-mentioned messages are only a partial representation of all the possible
warnings that the analyzer may output to the user. In case of any messages that are
not covered here or are not clear, please contact Technical Assistance Dept. at
Biotecnica Instruments S.p.A.
NOTE:
Specifications are subject to change without notice
PHOTOMETER
Optical System Solid state photometry, (patented by Biotecnica Instruments S.p.A.)
Detectors 10 UV/VIS photodiodes + reference channel
PRECISION AND ACCURACY
Spectral Response: 340, 380, 405, 436, 480, 510, 546 578, 630, 700 nm
Bandwidth: ± 5 nm max
Photometric precision: ± 1% from 0 to 2.000 O.D., ± 2.5% at 2-3 O.D.
Photometric Sensitivity: ± 0.001 ABS
Drift: ± 0.005 ABS/h (steady state)
7 mm for BT1000, BT2000 Plus & BT3000 Plus
Optical path: 5.9 mm for BT1500 & BT3500
Photometric Lamp: Tungsten Halogen Lamp with Dichroic Reflector
Beam Angle: 9º
Power: 35 Watts
Input voltage: 12 VDC
Avg Rated Life: Approximately 2000 hours
NOTE: For optimal result the lamp can be used for about 1,500 hours.
The long-term use will result in the gradual deterioration of the UV emission.
NOTE:
1 As regards the technical specifications for the system "instrumentation + reagent" used in the applications
of kit, these are the responsibility of kit’s manufacturer and will be stated in the applications (refer to the
instructions accompanying the kits).
2 The analyzer BT PLUS does not require (after sales) any routine electrical or mechanical readjustments.
There are mechanical and electronic adjustments performed by the manufacturer (Biotecnica Instruments
S.p.A.) during assembly and quality controls. These adjustments may be performed again in case required
by a particular technical service and in any case are at the discretion of the authorized technical personnel
only. However, It is highly recommended to check the system periodically to prevent any faults or
malfunction of the analyzer.
FOREWORD
This quick guide gives a global view of the system operation by outlining
the sequence of fundamental operating phases. It is highly
recommended to carefully read the whole manual in order to have a
deeper knowledge of each argument.
NOTE:
The BT instruments are automatic analyzers for clinical chemistry, immunochemistry analyses, and,
where available, for electrolytes determination through Ion Selective Electrodes (I.S.E. Module).
The analyzer can be divided into the following two distinct operative parts:
a) Sampling Unit: It prepares for tests the samples and single or double reagent.
b) Reading Unit: Cuvette plate with integral automatic washing system.
SYMBOLS
As the BT analyzers software runs under Windows, it uses the same philosophy with windows,
icons, quick commands, function keys and curtain-shaped menus.
Every window has its own icons and specific menus that will be described hereafter. The full
meaning of each command will be explained in the corresponding chapters.
At the start-up the program will display the following main window:
5
8
10
6 7 9
Figure 1
Figure 1
Start button
5) Verify the presence of the washing liquid (at least for the daily needs). It consists of bi-distilled
H2O plus surfactant (1ml/l of water - ratio 1/1000).
6) Verify that waste liquid containers are empty or at least have the capacity to contain the quantity
of liquid produced during the working day.
NOTE:
It is important to observe steps 5) and 6) to ensure a continuous operation of the analyzer without
interruptions.
Direct Access
Figure 2
Run a dilutor prime by the command Dilutor prime (Fig. 2).
Run a wash by the command Wash with water.
Password (F7)
4 - To Insert/Modify Profiles
6 - To Insert Batch
8 - To Run Controls
9 - Analyzer’s Utilities
10 - Mechanical Calibrations
12 - No Results
13 - Reaction Graphs
Simply positioning the cursor on the icons the hint will appear (where available), showing a brief
description of the icon function. This is followed (when available) by the function key between
brackets, which allows for the same function or command as the icon. For example, the hint Reset
(F5) means that the function key F5 has the same function of the icon. In the same way, in each
menu are shown (when available) the quick commands (e.g. Insert Batch (Ctrl+B) means that the
same function is activated by typing simultaneously on the keyboard the keys Ctrl and B).
GENERAL ICONS
Reduces the window to the upper bar where the analyzer's name appears.
An icon representing refrigeration system operation has been added to the status bar in the main
menu. The Refrigerator disabled state may be necessary if the operator decides not to use the
refrigerator for reactions or after a refrigeration operating error generated by the system.
Figure 3 Figure 4
This function is accessed either by pressing F10 key or by clicking on the specific icon. It helps the
user to correctly position the reagent bottles, as programmed in the current tray.
The reagent tray is divided into sectors, identified by the letters A, B and C for BT1000,
BT1500&BT2000 Plus, while for BT3000 Plus and BT3500, the letters are A, B, C, D and E. Each
sector has 8 positions. The screen displays the representation of 8+8 bottles (Figure 3). The
analysis codes that use large bottles are displayed in the lower positions, while the codes using
small bottles are displayed in the upper positions. The reagents volume status for the I.S.E. Module
and the sample diluent are illustrated in the Figure 4. The insertion of reagents in the reagent tray
for clinical chemistry, and in the I.S.E. Module is explained below.
Single bottle: Right-click over analysis code. Choose between bottle’s insertion or removal. The
analyzer will correctly position the tray to match with the arrow at the base of the tray itself. With
bar-code option enabled, identification is correctly accomplished through the automatic scan of the
bar code on the inserted bottle. The same function can be performed on demand, by activating the
Scan Bottle command (near the insertion/removal commands). Figure 5
Whole sector: Right-click on the SECTOR field. Choose between bottle’s insertion or removal. The
analyzer will correctly position the whole sector for insertion or removal. With bar-code option
enabled, identification is correctly achieved through the automatic scan of the bar code for the
inserted bottles. The same function can be performed on demand through Scan Sector (near the
sector insertion/removal commands).
In both cases, after insertion of the reagents, the analyzer will run a control of the volume of the
liquid present. Figure 5
Figure 5
NOTE: when using the Remove option, no functional control is performed: the
existing volume and test code are not removed.
Figure 4
Programming replicates on a single title
Enter 1 into the Number of samples, then enter the N. replicates (up to 4 max). Select the actual
position (Pos.) on the tray for the replicated standard and then the concentration (Conc.). The
values are automatically updated in the ABS boxes during the calibration and the factor will be
automatically calculated.
Programming several standards
Enter the number of standards to be used in the Number
of samples textbox. Enter the actual positions (Pos.) on
the tray for each standard and then the concentrations
(Conc.). The values are automatically updated in the ABS
boxes during the calibration and the factor will be
automatically calculated.
Calibration parameters
Max Var. (%) (Maximum percentage variation): This
parameter is for verifying percentage variation. It
represents the acceptable difference between the ABS
values calculated for the different calibration points, in
case more calibrators are used or repetitions are
performed on a single title. When an out-of-limit variation
occurs, a message informs the user and the calibration
will not be stored (the previous positive calibration will
remain in memory).
Figure 5
Section II Chapter 1 Abbreviated Operating Instructions Page 7 of 19
Reagent mABS: It is a read-only field and it is updated every time the blank reagent is performed.
% from last calibration: It is a percentage check made between current and previous calibration. It
compares the newly determined ABS with already stored data. If the programmed limit is surpassed,
then a message informs the user and the previous positive calibration will remain intact in memory.
Save: This command saves data and then closes the window.
Non Linear analyses: These tests require from 3 to 6 standards. Enter the number of standards to
be used in the Number of Samples field. Enter the actual positions (Pos.) on the tray for each
standard and then the related concentrations (Conc.). The values are automatically updated during
calibration into the ABS boxes.
To use standards pre-dilution function, enable the Automatic Dilution. It is then possible to select
whether dilution must be performed with water or physiological solution (Dilution with solution). In
the Dilution field enter the required dilution ratio. If automatic dilution is not required, then
appropriate concentration of the corresponding standard must be entered in the each concentration
field.
Graph: This command displays the graph of the stored interpolation curve. In the graphic display
page, data and curve are displayed together and can be printed.
Figure 7 Figure 8
Known: Enter lot name or number, mean value, and min & max limits. Enter tray’s position, already
set to controls in the section Setup Analyzer included in the inner ring of samples’ tray.
Unknown: Enter lot name or number and tray’s positions. Reserved positions are those already set
in the program Setup Analyzer, which are shared with known ones.
Figure 9 Figure 10
Figure 11
STAT: Displays STAT (Single Test in Actual Time, i.e. urgent positions) positions.
New Entry: Displays window for entering data of Routine, STAT and Control samples.
Extra Patients: Displays the list of patients with no assigned position. Patients selected in the work-
list may be moved here (Options menu, Send to extra patients command) and then back.
Figure 12
After the selection of Routine followed by confirmation through command New Entry, the patients
acquisition frame is displayed (Figure 12). The programmed patient can be executed immediately
or saved for later use. The programming fields and the functions are outlined below:
Code: It is the identification number assigned by the user to the patient. It is possible to assign an
already given code thus creating a clone of the patient. The cloning of a patient's code allows the
user to obtain one report in case different samples are used. If this option is not used, then separate
reports are obtained.
It is also possible to create multiple duplicates of the same patient, where the codes will be
automatically assigned and identified by the name Autobatch. These will have individual reports.
Surname, Name: Enter patient’s personal data.
Date: enter the test date.
Notes: enter additional notes.
External Dilution Factor: By default set to 1. It allows analysis determination on externally diluted
samples. Enter in this field the external dilution factor ratio used in sample preparation. Final result
is multiplied by the inserted external dilution factor.
Group: Select the group (Man, Woman, Child) for correct reference with normal values range.
Type: It is default set to Serum. The sample type (Serum or Urines) is selected here. If Urine is
selected, then the volume of diuresis is requested.
Assigned Group (Routine or CTRL Routine): The default setting is Routine. It is used for
selecting the category (Patient or Control Serum) during sample programming. Selecting CTRL
Routine the type (Known or Unknown) and levels (Level 1, 2, 3) must be specified.
Figure 13
Batch Entry: Click test code, then click each desired position (selected positions are highlighted in
red). Finally click on the checkbox by the code to activate the programmed batch. Select the Run
button to perform the patients. Refer to Figure 13.
Figure 14
Work Lists (Figure 14) are used to display the patient codes or to verify the status of the
samples in the tray together with the situation of Routines, STAT, Controls and Calibrators.
The Work Lists can be accessed through the menu Patients → Insert Routine/STAT or
using its direct access icon. The screen displays the Current Tray (Routine) in the center
and the Extra Patients (Routine) on the right. During the working phase, the Re-run is
also shown.
Click on the STAT, Controls and Standard buttons to view their worklists. For each the
Current Tray and the Extra Patients lists will be displayed. It is possible to perform patients
while running calibrations.
Figure 15 Figure 16
Options:
The Options menu is available in the Current Tray (Routine, STAT and
Controls). It displays the following commands:
Scan tray – Scan tray and run: performs a reading of the samples' tray and updates the patients
worklist. Selecting "scan and run" the analyzer will read tha samples' tray and start the patients run.
Figure 17
The Patient’s data display page is shown in Figure 17. It can be accessed through the
specific icon (shown on the right). It is a brief representation of data and allows
visualization of results of patient in execution as the tasks for the single patients are
completed. Once the results are archived, the information present in this page will no longer be
available.
In this area information related to calibrations is represented, such as the values of calculated
factors or any types of errors that occurred during execution.
If there is no data the page appears blank. A color code makes it possible to quickly identify the
information:
- red text: presence of flags in at least one test of the sample
- blue text: controls
- green text: calibrations
- black text: no anomaly in the test or the entire sample
a) Sample Position (#XX) Progressive number as programmed in the Setup dedicated page for
Routine and STAT.
Progressive number as programmed in the Setup dedicated page for
STD and CTRL.
b) Sample Code For Patients (Routine and STAT) it is assigned at check-in.
For STD and Batch it is automatically assigned.
It is automatically assigned for CTRL, but can be assigned by the
user during input. The relevant group level is also indicated (see
Chapter F, paragraph 1. “Quality Controls”).
c) Surname, Name Patient’s personal data.
d) Sample Type The relationship of Sample to one of the groups: Routine, STAT,
CTRL or STD is indicated between brackets.
e) Results The results of test attributed to patients are represented with:
Print: Print command. If enabled, it prints the entire contents of the data display page. However,
this is not a print-out in report format.
Sort: Data sorting command. This function is enabled only at the end of working session. The real-
time data are displayed in test execution order. The Sort command allows sorting based in the
following criteria, in this order: date, time, position on tray. The controls are places last and the
calibrations first.
Adjust: Data re-reprocessing command. This function is enabled only at the end of working
sessions. For patients re-run manually only the last result will be recalculated. The correction is
made starting with the absorbance memorized for the single test. After confirming the command and
selection of the desired analysis, two data re-processing modes are available. The first mode allows
a positive or negative percentage correction and the second mode uses the latest valid calibration
Archive Data: This command saves data into the patients archive.
Delete Results: deletes all the data from the visualization pages (per patients and in real time) as
well as the page of reaction graphs.
Exit: Exits from data display page.
INFO FLAGS
In both types of result displays (per patient and in real time) an Info Flags button is available on the
upper right.
It provides access to a page where the flags are located, with a short explanation of the meaning of
each one.
Figure 18
After the end of programmed task, the results can be viewed per Test. The test Results display
page is shown in Figure 18. Test results with flags are highlighted in red.
The following information is displayed for each single test:
a) Code and test name The displayed code is the same read on the list of tests, while the
full name between parenthesis is the one assigned by the operator
in the analytical parameters (chap. C, par. 1.3.3.).
b) Sample Position (#XX) Progressive number as programmed in the Setup dedicated page
for Routine and STAT.
Progressive number as programmed in the Setup dedicated page
for STD and CTRL.
c) Sample Code For Patients (Routine and STAT) it is assigned at check-in.
For STD and Batch it is automatically assigned.
e) Results The results of test attributed to patients are represented with:
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets – see also par. 1.5)
Figure 19
The data shown refer to the results obtained by the analyzer in real time (fig. 19), i.e. as the tests
are completed. The results are not sorted in any way, not per patient, not for type of test.
The data display is synthetic. The results of tests associated to flags are shown in red.
Once the results are archived, the information present in this page will no longer be available.
a) Sample Position (#XX) Progressive number as programmed in the Setup dedicated page for
Routine and STAT.
Progressive number as programmed in the Setup dedicated page for
STD and CTRL.
b) Sample Code For Patients (Routine and STAT) it is assigned at check-in.
For STD and Batch it is automatically assigned.
It is automatically assigned for CTRL, but can be assigned by the
user during input. The relevant group level is also indicated (see
Chapter F, paragraph 1. “Quality Controls”).
c) Date and time The date and time the test was run is between parenthesis.
d) Results The results of test attributed to patients are represented with:
- full name of the analysis
- execution method
- result
- unit of measurement
- absorbance read (between parenthesis)
- range of normal values
- any flags (between brackets – see also par. 1.5)
For automatic re-runs the values of the first and second
determination are represented.
1) SLEEP-MODE
This mode can be manually activated, or it starts automatically when the instrument is left inactive
for more than 30 minutes. The Sleep-Mode automatically performs the wash and fill up of the
cuvettes with bi-distilled water and remains idle (waiting for user’s commands for immediate
operation).
2) LOG-OFF
The Log-Off mode represents a partial turning off of the analyzer. It disables some devices: halogen
lamp of the photometer, cuvettes thermostat and drive motors. This mode is used for energy saving.
The Log-Off mode is utilized for programming automatic turning on at a desired date and time. The
instrument will remain in a stand-by condition and it will automatically turn on 30 minutes before the
programmed time. The turning on in anticipation (30 minutes before the programmed time) allows
the analyzer to reach steady state thus allowing immediate operation at the programmed time.
To exit ahead of time from a suspended activity, click on the left or right mouse button and press the
Exit button on the window that appears. However, in this case it is necessary to wait for the devices
to become operational (around 20 minutes).
CAUTION!
a) Do not ever stop the analyzer by turning off the main switch prior to performing
the correct SHUT DOWN procedure.
b) Improper shutdown may cause loss of data and programs and will necessitate
reinstallation of the operating software.
CHAPTER 2
2. WARRANTY CONDITIONS Page: 2
• Notes from the manufacturer Page: 3
• Parts / Instruments Return Authorization Page: 4
Mod.05-35a-ing Rev. 1
Parts / Instruments Return Authorization
DATE: ______/______/____
From:
To: Technical Assistance – Export Manager
Client information
Instrument model: Serial number:
Defective part
Part description:
Request for:
Repair Exchange Quotation Urgent
Name: Signature:
WARRANTY EXCTRACT: Biotecnica Instruments S.p.A. warrants its instruments to be free from defective parts and
workmanship for a period of one (1) year from the date of purchase. Liability under this warranty is expressly limited to
repair or replacement of defective parts at the option of Biotecnica Instruments S.p.A. This warranty does not cover the
results of misuse, accident or abuse of any parts of its instruments which have been repaired, tampered with or altered by
anyone other than personnel authorized by Biotecnica Instruments S.p.A. This warranty does not apply to fluid handling
devices, consumables or reagents.
Products returned to Biotecnica Instruments S.p.A. for repair or replacement shall be sent with transportation prepaid.
If found not to be defective under the terms of warranty, a charge will be made for repair or replacement and freight costs
will be at customer’s expense.
CHAPTER 3
3. ORDERING INFORMATION Page: 2
3.1. GENERAL TERMS AND CONDITIONS FOR SALE Page 2
3.2. Consumables for BT analyzers Page: 3
For additional information please visit our website at the following URL:
www.biotecnica.it
Important Notice:
Any modification to the Variable Serial Protocol is restricted to qualified personnel only. The
Biotecnica Instruments S.p.A. guaranties the correct performance of the internal serial
protocol. The responsibility for any malfunction arising out of any modifications to the
scripts of the Variable Serial Protocol rests with the customer.
WARNING
This information regards the setting up of the barcode for sample tubes
identification. The reading of the sample barcode label has the same
progression as patient code.
For example: Once a patient code of 15 characters has been entered,
then a code of 8 characters followed by 7 empty spaces to reach the 15
characters is sent.
The code read on the barcode label must have the same sequence 8 + 7
for correct detection.
IMPORTANT NOTICE ON DATA TRANSMISSION.
Any character below the "space" (value 32 decimal or 0x20 hexadecimal) at the
beginning or at the end of a patient code will be deleted. In this way it will be possible
to have a patient code shorter that 15 characters, without being obliged to use the
variable protocol. In case, after eliminating these characters, the resulting patient
code is empty, it will automatically be changed into '{0}'
4.1. GENERAL
The analyzer allows bi-directional communication through RS 232C serial connection with
any host computer.
The particular feature of the dialog is that it is always the host computer, which initiates the
communication for either transmitting patient list or for receiving the results.
To initiate any communication the host computer will have to send to analyzer the character
STX (0x02) and expect the character ACK (0x06) as a response. At this point the host
computer will send data to the analyzer and terminate the communication by sending the
character EOT (0x04).
It is important to remember that any communication is followed by a response from the
analyzer.
It must be noted that if the parameter to be transmitted is shorter in length than the length
requirement of the communication protocol than a space must be added before or after. For
example the analysis have length 4, therefore to send a code GLY one must add a space
after to reach the length of 4 characters.
If the communication is successful then the analyzer responds with character "Y" followed
by a byte, which identifies the position where patient has been inserted. In case the
communication was unsuccessful, then the analyzer responds with "N" followed by a byte
identifying the type of error. The possible errors generated by the analyzer in response to
the invalid insertion of patient are as follows:
For example to send a patient with code 000000000000001, serum type and with analysis
GLY, BUN and CHO onto the STATS list, then one must send the following sequence of
characters (excluding initial sequence STX<->ACK):
Where:
The following is an example of eventual response to the data sent in "Sending a patient to
BT ":
BT analyzer
BT analyzer
Introduction
The variable serial protocol has been designed to provide the user with possibility to
personalize the transmitted and received data from the analyzer.
The user can transmit or receive in addition to preset data (patient code, analysis code,
results etc.), also the simple text strings and/or characters in order to meet the personal
requirements.
Not only the user can decide to send or receive numerical information (for example number
of tests) not as single byte but as a preset numerical string or vice versa.
For example the user can decide to receive something like:
"Initiate analysis data"
<Analysis data true and typical>
"End analysis data"
Where the phrases "Initiate analysis data" and "End analysis data" do not refer to any
preset data by the analyzer but serve only for monitoring communication process (can be
useful for inserting specific markers on those programs which obtain information from text
files).
It is obvious that the protocol of initiation and end of communication, the commands for the
request of report, and the analyzer responses in case of error or success remain identical to
the usual preset serial communication.
NOTE:
a) If a check-sum is omitted in a communication then the analyzer will not control it.
b) The following numbers have been used to represent the error codes relevant to
sending a patient to the analyzer as regards the parameters not part of the
standard serial communication:
0x0F Data (constant) sent to a TAG #Char, #String or #Stringn does not fall within the
possible values range
0x10 Data (variable) sent to a TAG #Char, #String or #Stringn is not valid
0x11 An analysis variable is outside the SET BEGIN/END relative to the analysis
An editor for writing, modifications, saving and compiling of one or more scripts is
accessible inside the program (setup function). In any case it is possible to write a script
with any text editor (DOS or Windows) like Notepad of Windows or the EDITOR of the DOS.
It is not possible to import documents written with UNIX as the characters used for going to
the next line are different from the ones used by the DOS or Windows.
CAUTION!
If one wants to use the script stored in a removable disk (for example floppy disk)
then it will be necessary to copy it on the hard disk.
TYPE OF DATA
Character: Identifies a single character, can pass as printable character (enclosed between single
apostrophes), as decimal ASCII value (followed by symbol $) or else hexadecimal ASCII
value (followed by 0x).
If for example we want to identify the character A (decimal value 65 or
hexadecimal value 41) then we can write 'A', $65 or 0x41.
String: Identifies a sequence of printable characters enclosed in single apostrophes, for example:
'this is a string'.
Comment: Identifies a portion of test (preceded by a character ; which will not be compiled but will
serve as note only for the programmer.
Variables: These are particular sequence of characters preceded by the symbol #, which will be
used by the program for storing internal information (patient code, analysis name and
etc.), refer to "TABLE 1 - TRANSMISSION/RECEPTION".
There are also variables for direct uses, which allow for identification of
any character below ASCII 32 (space) to facilitate the writing of the script
(for example, one can use the variable #EOT to identify the character $4),
see "TABLE 2 - INTERNAL VARIABLES".
Syntax:
String <string>I<Terminator>
Where
<String> Transmit/receive string
<Terminator> End character
Note:
It is not possible to use the variables like parameter <Terminator>
Example:
String ‘Hello Word’|$0
String ‘My String’|’@’
String #Variable1|0x10
Syntax:
Stringn <String>|<Length>
Where
<String> Transmit/receive string
<Length> String length
Note:
If the length of the text strings is less than the data length then a series of spaces will
be added on the right to reach the data preset length. In case the text string is longer
than the data length then the string end will be cut off to match the data length.
If the length of the numerical values is less than the data length then a series of
characters '0' will be added to the left to reach the preset data dimension. In case the
length of the numerical values string is longer than the data length then the string will
be truncated to match the data length.
Example:
Stringn ‘Hello Word’|$40
Stringn #Variable1|0x10
Syntax:
Char <Character>
Example:
Char ‘H’
Char $20
Char 0x10
Char #STX
Set: Identifies the beginning and the end of the group of repetitive commands
Syntax
Note:
Actually the ANALYSESDATA is the unique SET present, which identifies the
analysis in transmission/reception.
Only one command SET BEGIN and one command SET END can be present in a
script.
A script must always contain the command SET.
The variable PATIENTNUMBERTEST must be present before the command SET.
The following variables are used for the transmission of a report from analyzer to the host
computer:
Variable Usage Type of valid data
PATIENTCODE Patient Code String
PATIENTNAME Patient Name String
PATIENTSURNAME Patient Surname String
PATIENTGROUP Group (1) String Character
PATIENTLISTTYPE List (2) String Character
PATIENTTYPE Method Type (3) String Character
PATIENTNOTE Descriptive Note String
PATIENTNUMBERTEST Number of Results String Character
CHECKSUM Check-Sum String Character
ANALYSESCODE Analysis Code String
ANALYSENAME Analysis name String
ANALYSESTYPE Analysis Type (4) String Character
ANALYSESCONCENTRATION1 1st Concentration String
ANALYSESCONCENTRATION2 2nd Concentration String
ANALYSESFLAGS1 Flag 1st Result String
ANALYSESFLAGS2 Flag 2nd Result String
ANALYSESMINVALUE Minimum Value String
ANALYSESMAXVALUE Maximum Value String
ANALYSESUM1 1st Unit of Measurement String
ANALYSESUM2 2nd unit of measurement String
ANALYSESUMFACTOR Unit Factor String
ANALYSES2RESULT Does the 2nd result exists? (5) String Character
ANALYSESSERUMTYPE Method Type (3) String Character
ANALYSESURINE24H Urine in 24/h String
(1)
Identifies Male, Female or Child (Select one of these):
‘M’ : Male
‘F’ : Female
‘C’ : Child
(2)
Identifies Routine or STAT (Select one of these):
‘R’ : Routine
‘S’ : STAT
Transmitting patient from archive will always have identifier of Routine.
(3)
Identifies Serum or Urine (Select one of these):
‘S’ : Serum
‘U’ : Urine
(4)
Identifies Clinical Chemistry, or Relation Analysis (Select one of these):
‘C’ : Clinical Chemistry
‘R’ : Relation Analysis
(5)
Identifies if the 2nd result exists or not (Select one of these):
‘Y’ : 2nd result exists
‘N’ : 2nd result does not exist
• If only the final result is desired then always refer to variables pertaining to 2nd result.
• In case of the absence of 2nd result then its variables will have the same values of the 1st result.
The following variables are used for reception of a patient by the analyzer:
Variable Usage Type of valid data
PATIENTCODE Patient Code String
PATIENTNAME Patient Name String
PATIENTSURNAME Patient Surname String
PATIENTLISTTYPE List (1) String Character
PATIENTGROUP Group (2) String Character
PATIENTTYPE Method Type (3) String Character
PATIENTURINE24H Urine in 24/h String
PATIENTNOTE Descriptive Note String
PATIENTISCONTROL If the patient is a control (4) String Character
PATIENTCONTROLKNOK If it is a known control (5) String Character
PATIENTCONTROLLEVEL Control Level (6) String Character
PATIENTCLONE If it is a clone (7) String Character
PATIENTCUPPOSITION Vial (Cup) position String Character
PATIENTNUMBERTEST Number of test String Character
CHECKSUM Check-Sum String Character
ANALYSESCODE Analysis Code String
(1)
Identifies Routine or STAT (Select only one of these):
$0 : Routine
$1 : STAT
‘0’ : Routine
‘1’ : STAT
‘R’ : Routine
‘S’ : STAT
‘ROUTINE’ : Routine
‘STAT’ : STAT
(2)
Identifies Male, Female or Child (Select only one of these):
$0 : Male
$1 : Female
$2 : Child
‘0’ : Male
‘1’ : Female
‘2’ : Child
‘M’ : Male
‘F’ : Female
‘C’ : Child
‘MAN’ : Male
‘FEMALE’ : Female
‘CHILD’ : Child
(3)
Identifies Serum or Urine (Select only one of these):
$0 : SERUM
$1 : URINE
‘0’ : SERUM
‘1’ : URINE
‘S’ : SERUM
‘U’ : URINE
‘SERUM’ : SERUM
‘URINE’ : URINE
$0 : Sample
$1 : Control
‘0’ : Sample
‘1’ : Control
‘N’ : Sample
‘Y’ : Control
‘S’ : Sample
‘C’ : Control
‘NO’ : Sample
‘YES’ : Control
‘SAMPLE’ : Sample
‘CONTROL’ : Control
(5)
Identifies a Known or Unknown Control (Select only one of these):
$0 : Unknown
$1 : Known
‘0’ : Unknown
‘1’ : Known
‘N’ : Unknown
‘Y’ : Known
‘U’ : Unknown
‘K’ : Known
‘NO’ : Unknown
‘YES’ : Known
‘UNKNOW’ : Unknown
‘KNOW’ : Known
(6)
Identifies Control Level (Select only one of these):
$1 : Level 1
$2 : Level 2
$3 : Level 3
‘1’ : Level 1
‘2’ : Level 2
‘3’ : Level 3
‘L’ : Level 1
‘N’ : Level 2
‘A’ : Level 3
‘LOW’ : Level 1
‘NORMAL’ : Level 2
‘ABNORMAL’ : Level 3
(7)
Identifies if it is a Clone (Select only one of these):
$0 : Normal
$1 : Clone
‘0’ : Normal
‘1’ : Clone
‘N’ : Normal
‘Y’ : Clone
‘NOCLONE’ : Normal
‘CLONE’ : Clone
The examples outlined here are the transformation in script of the standard routine of the
patient reception by the analyzer.
Stringn #PatientCode|$15
Char #PatientListType
Char #PatientType
Char #PatientClone
Stringn #PatientCupPosition|$2
Stringn #PatientNumberTest|$2
Set #BeginAnalysesData
Stringn #AnalysesCode|$4
Set #EndAnalysesData
Stringn #CheckSum|$3
Stringn #PatientCode|$15
Patient Code of fixed length equal to 15 characters
Char #PatientListType
Type of list (Routine/STAT) as single character
Char #PatientType
Serum type (Serum/Urine) as single character
Char #PatientClone
Identifies if the patient is or is not a clone (single character)
Stringn #PatientCupPosition|$2
Position of serum cup (string of fixed length equal to 2 characters)
Stringn #PatientNumberTest|$2
Number of tests to be executed (string of fixed length equal to 2 characters)
Set #BeginAnalysesData
Beginning of analysis codes
Stringn #AnalysesCode|$4
An analysis code of fixed length equal to 4 characters. It must be entered for each type of test
as per qty indicated in the #PatientNumberTest.
Set #EndAnalysesData
End of analysis codes
Stringn #CheckSum|$3
Check-Sum (transferred as a string of fixed length equal to 3 characters)
Stringn #PatientCode|$15
Char #PatientType
stringn #PatientNumberTest|$3
Set #BeginAnalysesData
Stringn #AnalysesCode|$04
Stringn #AnalysesConcentration2|$7
Set #EndAnalysesData
Stringn #CheckSum|$3
Stringn #PatientCode|$15
Patient Code of fixed length equal to 15 characters
Char #PatientType
Serum type (Serum/Urine) as single character
stringn #PatientNumberTest|$3
Number of results to be sent (a string of fixed length equal to 3 characters)
Set #BeginAnalysesData
Beginning of zone repeated for the number of results to be sent (see #PatientNumberTest)
Stringn #AnalysesCode|$04
An analysis code of fixed length equal to 4 characters
Stringn #AnalysesConcentration2|$7
Concentration referred to the analysis code as per #AnalysesCode (a string of fixed length
equal to 7 characters)
Set #EndAnalysesData
End of zone repeated for the number of results to be sent
Stringn #CheckSum|$3
Check-Sum (transferred as a string of fixed length equal to 3 characters)
Baude-Rate....................... 9600
Stop-Bits........................... 1
Parity................................. None
Hand-shake...................... Hardware
IMPORTANT NOTICE: These two programs are in the installation disk under Utility folder.
CHAPTER 5
5. INSTALLATION OF THE OPERATING SYSTEM Page: 2
5.1. Preliminary Phase Page: 2
5.2. Setup of the Operating System Page: 5
5.3. Completing the installation Page: 9
5.4. Settings of the Operating System Page: 11
5.5. Installation of BT analyzers Program Page: 15
5.6. Upgrading the BT analyzers software Page: 16
5.7. Installation with Image Disk Page: 17
NOTE:
Now the Setup copies files to the Windows 2000 installation folders in the hard disk and this
may take several minutes to complete:
At the end of preceding phase the system will restart (DO NOT REMOVE CD-ROM FROM
CD-ROM DRIVE).
CAUTION
DO NOT INTERRUPT THIS OPERATION!!!
Now type the Product Key of Windows (the Product Key is composed of 5 groups of 5
characters each):
In case the board has a LAN (network) communication hardware, then the following
screens will be displayed:
Do not change the default parameters and click “NEXT” in both the screens.
The second phase of the installation has been successfully completed. Remove CD from
the drive. Click "Finish" to restart the system:
Open Control Panel: Click “Start”, point to “Settings”, and click “Control Panel”.
Go to “Screen Saver”:
Click “OK”.
If one desires to select a background picture go to "Background" page.
Select the desired background picture and set “Stretch” in the "Picture Display".
Click “OK”.
If a question is asked then respond by clicking “Yes”:
CAUTION:
The supplementary drivers must be installed prior to installation of the BT operating program in the
system.
Click “NEXT”.
Here the operator will manually select the Com port used for communication (normally "Com4"
is utilized).
Select Com4 and click “Accept”. Now the installation of operating programs begins.
CAUTION:
DO NOT INTERRUPT THE ONGOING INSTALLATION, UNLESS FOR SERIOUS REASONS.
After the termination of previous phase, a message "Setup has finished installing bt Plus on
your computer" will be displayed:
Click “Finish”.
Now a screen with various options for "End installation" (with restart or without restart of the
system) is displayed.
In case of the new installation, select "Yes, I want to restart my computer now" (first option).
Now the operating program has been installed correctly in the system.
CHAPTER 6
6. TECHNICAL ASSISTANCE Page: 2
In case of need for the Technical Assistance Service, before calling Biotecnica, please
make sure that the following information is available:
- analyzer model
- serial number
- program code (at the center of the main screen)
- analyzer configuration (printable from the External programs menu, with third level
password)
For operative and applications problems, make sure all possible information is available (in
addition to the above mentioned), such as:
Please do not return any equipment or part of the system to Biotecnica before discussing
your problem with an authorized technical assistance representative or Biotecnica own
technical assistance. The Technical Assistance Service at Biotecnica Instruments S.p.A.
will provide a Return Authorization Number for the Parts/Instruments Return
Authorization module available in Section II, chapter 2.
à www.biotecnica.it
CHAPTER 7
7. BIBLIOGRAPHY OF ALLIED SUBJECTS Page: 2
NOTE:
The following bibliography is given to supplement this manual,
whose scope as an operator manual permits only the mention or
brief explanation of some subjects.
♦ Burtis C.A., Ashwood E.R.: “Tietz Textbook of Clinical Chemistry” IInd Ed. W.B.
Saunders Company, 1994
♦ Press W.H., Flannery B.P., Teukolsky S.A., Vetterling W.T.: “Numerical Recipes” -
The Art Of Scientific Computing -, Cambridge Univ. Press, 1986
♦ EN 591 (1994): In vitro diagnostic systems – Requirements for user manuals for in
vitro diagnostic instruments for professional use (ital. UNI 96)
CHAPTER 8
8. LIST OF APPLICABLE METHODOLOGIES Page: 2
For further details on the applied methodologies, please address to the following e-mail:
bt@biotecnica.it